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)
Effect of pneumococcal Haemophilus influenzae protein D conjugate vaccine
(PHiD-CV10) on outpatient antimicrobial purchases: a double-blind, cluster
randomised phase 3-4 trial. 
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. 
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. 
clinical endpoints... CONCLUSIONS: PCV13 resulted in lower acquisition and prevalence of NP
Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in
healthy infants and toddlers given with routine vaccines in India. 
double-blind trial conducted at 12 sites in India... CONCLUSIONS: PCV13 has immunogenicity similar to PCV7 in response to the 7 common
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. 
conjugate vaccine (PCV13)... CONCLUSION: In adults aged 70 years and older previously vaccinated with PPSV23,
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.
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.
Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in HIV-Infected Subjects 6 Years of Age or Older Who Are Naive to Pneumococcal Vaccine [Recruiting]
The study will evaluate the safety, tolerability and immunogenicity of a 13-valent
pneumococcal conjugate vaccine (13vPnC) in HIV-infected subjects 6 years of age or older who
have not been previously immunized with a pneumococcal vaccine. All subjects will receive 3
doses of 13vPnC and 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), with
each dose given approximately 1 month apart.
Pneumococcal Conjugate Vaccine With Pneumococcal Polysaccharide Vaccine and Tetanus/Diphtheria Vaccine [Active, not recruiting]
The purpose of this study is to learn whether or not giving a tetanus/diphtheria vaccination
("tetanus shot") before giving pneumococcal vaccine makes the pneumococcal vaccine more
effective without causing too many side effects.
Page last updated: 2014-12-01