If they are serious about studying this properly, they will include NEVER vaccinated children and adults in their studies. - SM
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?uid=11709767&form=6&db=m&dopt=r
|
Clin Infect Dis 2001 Dec 15;33 Suppl 4:S323-6 |
Books
Perspectives on the design and analysis of
prelicensure trials: bridging the gap to postlicensure studies.
Black S.
Kaiser Permanente Vaccine Study Center, Oakland, CA 94612, USA.
Steve.Black@kp.org
Recently, there has been growing concern regarding vaccine safety. Vaccines
have led to the eradication of many serious diseases. Accordingly, there is
less familiarity with the consequences of diseases and increasing concern with
potential rare adverse events. The availability of clinical information systems
within health maintenance organizations makes assessment of safety in larger
cohorts, with power to assess rare adverse events, possible. However, no trial,
no matter how large, can rule out all possible adverse events. There will
always be the possibility that a rarer adverse event-just beyond the power of
detection of a given trial-may occur. It is proposed that prelicensure trials
in 10,000-40,000 children are now feasible. However, it will be necessary to
develop an analytic continuum in which prelicensure studies are followed up
with postmarketing assessments. Accordingly, the rapid identification of
intussusception as a complication of rotavirus vaccination should not be seen
as a failure of prelicensure studies but rather as a positive example of an
effective integrated safety assessment program.
Publication Types:
·
Review
·
Review, Tutorial
MeSH Terms:
·
Child
·
Clinical Trials, Phase III
·
Diphtheria-Tetanus-acellular Pertussis Vaccines/adverse
effects
·
Gastroenteritis/etiology
·
Human
·
Meningococcal Vaccines/adverse effects
·
Pneumococcal Vaccines/adverse effects
·
Product Surveillance, Postmarketing
·
Research Design
·
Rotavirus Vaccines/adverse effects
·
Sample Size
·
Vaccines, Combined/adverse effects*
Substances:
·
heptavalent pneumococcal conjugate vaccine
·
Vaccines, Combined
·
Rotavirus Vaccines
·
Pneumococcal Vaccines
·
Meningococcal Vaccines
·
Diphtheria-Tetanus-acellular Pertussis Vaccines
PMID: 11709767 [PubMed - indexed for MEDLINE]
ALL
INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR
GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE
KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED
AS PROVIDING MEDICAL OR LEGAL ADVICE. THE DECISION WHETHER OR NOT TO
VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU
ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.