Safety and Local Tolerability of Prevenar in Indian Children
Summary
This postmarketing surveillance study will evaluate the safety profile of Prevenar in Indian children.
Prevenar is indicated for active immunization of infants and children from 6 weeks of age through 9 years of age against invasive disease (including meningitis, bacteraemic pneumonia, bacteraemia, sepsis) caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F.
Prevenar has been marketed in India since June 2006. The Board of Health in India has given restricted permission to import and market Prevenar. The present study is a post-approval regulatory commitment to the Board of Health in India.
This is an observational study and the protocol for the study has been approved by the Board of Health.
Study Design
Time Perspective: Prospective
Conditions
Pneumococcal Infections
Intervention
pneumococcal conjugate vaccine
Status
Completed
Source
Wyeth
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00488800
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Pneumococcal Infections
Infections with bacteria of the species STREPTOCOCCUS PNEUMONIAE.
Pneumococcal Vaccines
Vaccines or candidate vaccines used to prevent infections with STREPTOCOCCUS PNEUMONIAE.
Pneumonia, Pneumococcal
A febrile disease caused by STREPTOCOCCUS PNEUMONIAE.
Meningitis, Pneumococcal
An acute purulent infection of the meninges and subarachnoid space caused by Streptococcus pneumoniae, most prevalent in children and adults over the age of 60. This illness may be associated with OTITIS MEDIA; MASTOIDITIS; SINUSITIS; RESPIRATORY TRACT INFECTIONS; sickle cell disease (ANEMIA, SICKLE CELL); skull fractures; and other disorders. Clinical manifestations include FEVER; HEADACHE; neck stiffness; and somnolence followed by SEIZURES; focal neurologic deficits (notably DEAFNESS); and COMA. (From Miller et al., Merritt's Textbook of Neurology, 9th ed, p111)
Diphtheria-tetanus Vaccine
A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.
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Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.
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