Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Prevnar® , is a sterile solution of saccharides of the capsular antigens of
serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F individually conjugated to diphtheria CRM197 protein. Each serotype is grown in soy peptone broth. The individual polysaccharides are purified through centrifugation, precipitation, ultrafiltration, and column chromatography.
Prevnar® is indicated for active immunization of infants and toddlers against invasive disease caused by
due to capsular serotypes included in the vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F). The routine schedule is 2, 4, 6, and 12-15 months of age.
The decision to administer Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Prevnar® should be based primarily on its efficacy in preventing invasive pneumococcal disease. As with any vaccine, Prevnar® may not protect all individuals receiving the vaccine from invasive pneumococcal disease.
Prevnar® is also indicated for active immunization of infants and toddlers against otitis media caused by serotypes included in the vaccine. However, for vaccine serotypes, protection against otitis media is expected to be substantially lower than protection against invasive disease. Additionally, because otitis media is caused by many organisms other than serotypes of
represented in the vaccine, protection against all causes of otitis media is expected to be low.
Published Studies Related to Prevnar (Pneumococcal Vaccine)
Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D
conjugate vaccine (PHiD-CV10) against invasive pneumococcal disease: a cluster
randomised trial. 
invasive pneumococcal disease... INTERPRETATION: This nationwide trial showed high PHiD-CV10 effectiveness against
Immunogenicity, safety, and reactogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine and DTPa-IPV-Hib when coadministered as a 3-dose primary vaccination schedule in The Netherlands: a randomized controlled trial. [2011.09]
CONCLUSIONS: : PHiD-CV and DTPa-IPV-Hib were immunogenic and well tolerated when coadministered as a 3-dose primary vaccination course.
Pneumococcal conjugate vaccination at birth in a high-risk setting: no evidence for neonatal T-cell tolerance. [2011.07.26]
Concerns about the risk of inducing immune deviation-associated "neonatal tolerance" as described in mice have restricted the widespread adoption of neonatal vaccination. The aim of this study was to demonstrate the immunological feasibility of neonatal pneumococcal conjugate vaccination (PCV) which could potentially protect high-risk infants in resource poor countries against severe pneumococcal disease and mortality in the early critical period of life...
Serotype-specific avidity is achieved following a single dose of the 7-valent pneumococcal conjugate vaccine, and is enhanced by 23-valent pneumococcal polysaccharide booster at 12 months. [2011.06.15]
AIM: To evaluate whether the avidity of serotype-specific IgG to pneumococcal serotypes is enhanced by an increased number of doses of the 7-valent pneumococcal conjugate vaccine (PCV) in infancy or by a 12 month 23-valent pneumococcal polysaccharide vaccine (23vPPS) booster, and/or subsequent re-exposure to a small dose of pneumococcal polysaccharide antigens (mPPS) at 17 months... CONCLUSIONS: By 9 months of age, similar avidity can be induced following one, 2 or 3 doses of PCV. A 23vPPS booster at 12 months enhanced affinity maturation with an increase in antibody avidity for most serotypes. Subsequent re-challenge with mPPS at 17 months did not further enhance the avidity of serotype-specific response in the 12 month 23vPPS groups. Copyright (c) 2011 Elsevier Ltd. All rights reserved.
The immunogenicity and impact on nasopharyngeal carriage of fewer doses of conjugate pneumococcal vaccine immunization schedule. [2011.04.05]
The immunogenicity and impact on carriage of fewer doses of pneumococcal conjugate vaccine (PCV7) followed by booster with pneumococcal polysaccharide vaccine (PPV) were investigated. 684 infants were assigned randomly to one of the three groups that received one (A), two (B) or three (C) doses of PCV7 between 2 and 4 months of age, plus PPV at 10 months.
Clinical Trials Related to Prevnar (Pneumococcal Vaccine)
Study Evaluating Antibody Response of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children Previously Given PnC [Recruiting]
This is an open-label study (a study in which the doctors and participants know which drug
or vaccine is being administered) in children who previously received a 4-dose series of a
pneumococcal conjugate vaccine (PnC) during infancy in Study 6096A1-008-EU (NCT00366678).
In this study, participants will receive an additional dose of 13-valent pneumococcal
conjugate vaccine. The purpose of this study is to evaluate persistence, if any, of the
antibody response by measuring any remaining pneumococcal antibodies since the previous
study. This study will also evaluate the safety and immunogenicity of 13-valent
pneumococcal conjugate vaccine when administered at least 24 months after the last dose of
pneumococcal conjugate vaccine.
A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria [Recruiting]
A vaccine called Prevenar is already approved for use in China for vaccination of children
younger than 6 years old against infections caused by Streptococcus pneumoniae.
This study is to measure the amount of antibodies (antibodies help people fight off
diseases) Chinese children aged between 121 days and 6 years (72 months) produce when given
Prevenar. The study will also provide more data on how safe and well tolerated Prevenar is
in Chinese children.
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.
Immunogenicity of Repeated Dose 13-valent Pneumococcal Conjugate Vaccine Compared to the Pneumococcal Polysaccharide Vaccine in Adult Kidney and Liver Transplant Patients [Recruiting]
Severe Pneumococcal disease, such as bacteremia, meningitis and pneumonia, cause significant
morbidity and mortality in both otherwise healthy adult population and in the
immunocompromised patients. The incidence rate of invasive pneumococcal disease is
considerably higher among organ transplant patients than in healthy individuals. Routine
immunization with Pneumococcal vaccine is recommended pretransplant and once 3-5 years after
the transplantation. The efficacy and immunogenicity of Pneumococcal polysaccharide
vaccine(Pneumovax®) is suboptimal in this patient group. The conjugate Pneumococcal vaccine
has been shown to be more immunogenic and safe in some other subgroups of immunocompromised
patients. We intend to compare the immunogenicity of repeated dose 13-valent Pneumococcal
conjugate vaccine (Prevenar13®)to the existing recommended protocol of Pneumococcal
polysaccharide vaccine (Pneumovax®) in adult kidney and liver transplant patients.
Pneumococcal Conjugate Vaccine Followup [Recruiting]
Recently, controversy has emerged regarding the role of the 23vPPV in infants due to
potential immunological hypo-responsiveness (i. e. a poorer immune response to repeat
vaccination). Although previous experience of 23vPPV in children in PNG has demonstrated
protective efficacy against acute lower respiratory tract infection, the investigators feel
it is a matter of urgency to determine if 23vPPV administration provides elevated antibody
concentrations at 3 to 5 years of age, and to ensure the immunological safety of the 23vPPV
Following consent and eligibility assessment, a baseline blood sample and nose swab will be
taken, a 0. 1ml dose of 23vPPV will be administered and a follow up blood sample and nose
swab will be collected 28 days later. The investigators will also collect data on incidence
of ALRI in all study participants by medical record review.
Page last updated: 2013-02-10