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Pneumovax (Pneumococcal Vaccine Polyvalent) - Summary



PNEUMOVAX * 23 (Pneumococcal Vaccine Polyvalent) is a sterile, liquid vaccine for intramuscular or subcutaneous injection. It consists of a mixture of highly purified capsular polysaccharides from the 23 most prevalent or invasive pneumococcal types of Streptococcus pneumoniae, including the six serotypes that most frequently cause invasive drug-resistant pneumococcal infections among children and adults in the United States. (See Table 1.) The 23-valent vaccine accounts for at least 90% of pneumococcal blood isolates and at least 85% of all pneumococcal isolates from sites which are generally sterile as determined by ongoing surveillance of U.S. data.

PNEUMOVAX 23 is indicated for vaccination against pneumococcal disease caused by those pneumococcal types included in the vaccine.
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Published Studies Related to Pneumovax (Pneumococcal Vaccine Polyvalent)

Polysaccharide conjugate vaccine against pneumococcal pneumonia in adults. [2015]
pneumonia in adults 65 years of age or older is unknown... CONCLUSIONS: Among older adults, PCV13 was effective in preventing vaccine-type

Effect of pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) on outpatient antimicrobial purchases: a double-blind, cluster randomised phase 3-4 trial. [2014]
antimicrobial purchases... INTERPRETATION: Despite low relative rate reductions the absolute rate reductions

Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against invasive pneumococcal disease: a cluster randomised trial. [2013]
invasive pneumococcal disease... INTERPRETATION: This nationwide trial showed high PHiD-CV10 effectiveness against

Comparative immunogenicity and efficacy of 13-valent and 7-valent pneumococcal conjugate vaccines in reducing nasopharyngeal colonization: a randomized double-blind trial. [2013]
clinical endpoints... CONCLUSIONS: PCV13 resulted in lower acquisition and prevalence of NP

Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults 70 years of age and older previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. [2013]
conjugate vaccine (PCV13)... CONCLUSION: In adults aged 70 years and older previously vaccinated with PPSV23,

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Clinical Trials Related to Pneumovax (Pneumococcal Vaccine Polyvalent)

Systems Biology of PNEUMOVAX�23 and PREVNAR 13� [Active, not recruiting]
Vaccination is the most effective way of preventing infectious diseases. Despite the success of vaccines in general, vaccines induce diminished antibody responses and lower protection in the elderly in particular. This could be explained by a defect in the early responses of an ageing immune system. A better understanding of the basic immunological mechanisms that mediate vaccine efficacy is incomplete. Such information is critical and could greatly decrease both the cost and the time to new vaccine development particularly for the geriatric population. In this trial, the investigators will study the immunologic differences of two FDA approved licensed pneumococcal vaccines between a younger and an older group. Twenty two healthy volunteers between the age of 25-40 and sixty six healthy volunteers between the ages of 60-89 will be enrolled in the study. Each participant in the study will be given one pneumococcal shot. Blood work will be obtained prior to vaccination, one day, three days, seven days, fourteen days, as well as one month and six months after vaccination. Throughout the duration of the study, the participants will be monitored for safety.

The Effect of Short-term Atorvastatin Treatment on Immune Responses to Pneumovax 23 [Completed]

A Study to Compare the Safety and Immunogenicity of Pneumococcal Conjugate Vaccines in Healthy Volunteers (V114-002) [Completed]
The purpose of the study is to see if an investigational vaccine for Streptococcus pneumonia disease (V114) has comparable safety, tolerability, and antibody response to Pneumococcal Polysaccharide Vaccine (Pneumovax 23) and 13-valent Pneumococcal Conjugate Vaccine (Prevnar 13) when administered to healthy adults 50 years of age or older.

Immunogenicity of Pneumococcal Vaccines in Ataxia-telangiectasia Patients [Not yet recruiting]
Ataxia-telangiectasia (AT) is a rare genetic disorder characterized by gait disorders, neuromotor dysfunction, eye abnormalities and immune deficiency. AT patients are vulnerable to cancer and infection and usually die during their 2nd or 3rd decade due to these complications. The main cause of death is respiratory infections because these patients are known to have severe type of immunodeficiency. Consequently, pneumonia is the most common infection seen in AT patients, and is usually caused by S. pneumoniae. Therefore, a routine schedule of pneumococcal vaccine is highly recommended in AT cases where immunoglobulin replacement therapy was not already initiated. Until recently, AT patients were immunized with the pneumococcal polysaccharide vaccine (PPV23, Pneumovax® Aventis Pasteur MSD). However, data have shown that they do not respond well to these vaccines. Recently, the Israeli Ministry of Health has approved the pneumococcal 7-valent conjugate vaccine (PCV7, Prevenar®, Wyeth Lederle) for AT patients of all ages. This conjugate vaccine is known to stimulate the immune system through a different mechanism and the response is expected to be higher. The approved Israeli schedule for immunization of AT patients includes children older than 2 years that are entitled to receive 2 doses of PCV7 (8 weeks apart) boosted by PPV23, eight weeks after the second dose of PCV7. Assessment of the antibody response of such pneumococcal vaccination protocol in AT patients has never been performed. The "Safra" Children's Hospital is the national multi-disciplinary center caring for AT patients. Approximately 50 patients from all over the country (including Jewish, Druze,

Bedouin and other Muslim patients - 3 of whom are Palestinians) are followed in the clinic

on a monthly basis. Approximately 20 AT patients are not receiving IVIG replacement therapy, therefore are

entitled to receive pneumococcal vaccination as stated above (mean age 10. 6, 3 - 23 years, 3

less than 5 years) The aim of this study is to evaluate the responsiveness, determined by specific antibody production, of AT patients receiving this new vaccine protocol.

Safety and Immunogenicity of a 10 Valent Pneumococcal Conjugate Vaccine (SIILPCV10) in Healthy Adults, Toddlers, Infants [Recruiting]
Phase 1/2, Prospective, Single Center, Randomized, ActiveControlled, Double-Blind, Age De-escalation Study to assess the safety and tolerability of SIILPCV10 administered as a single-dose regimen to healthy Gambian pneumococcal conjugate vaccine (PCV)-nave young adults and PCV-primed toddlers through 4 weeks post vaccination. Each adult and toddler subject will undergo a total of 4 clinic visits. Each infant subject will undergo a total of 9 scheduled visits. Blood will be collected from all subjects during the screening visit for safety and potential immunological assessments, and 28 days after completion of the vaccination schedule for immunological assessments. For adults, the vaccine will be given IM into the mid-deltoid muscle of nondominant arm using a 24-gauge needle. For toddlers and infants, the vaccine will be given IM into the anterolateral aspect of the left thigh. Blood will be collected from adults and toddlers for safety labs at the Day 7 post-vaccination visit.

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Page last updated: 2015-08-10

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