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Vaccine Trial Information

A vaccine trial is a clinical trial that aims at establishing the safety and efficacy of a vaccine prior to it being licensed.

Methodology

A basic vaccine trial might involve forming two groups from a random sample of the target population. One group receives the vaccine while the control group receives a placebo, an adjuvant-containing cocktail, or a different vaccine which might be intended to protect against a different pathogen. Data on antibody production and immunity to the disease in question is collected from both groups some time after the administration of the vaccine or placebo, and a statistical test is performed on these two sets of data to determine whether or not there is any statistically significant difference between them. If the vaccine produces no statistically significant results, then it is rejected. Side effects of the vaccine are also noted, and these too contribute to the decision on whether to license it.

Methodological issues and problems

Vaccine trials may take months or years to complete, since a sufficient time period must elapse for the subjects to react to the vaccine and develop the required antibodies.

Artificial induction of immunity / Immunization: Vaccines, Vaccination, and Inoculation (J07)
Development

List of vaccine ingredients · Adjuvants · Mathematical modelling · Timeline · Trials

Classes: Inactivated vaccine · Live vector vaccine (Attenuated vaccine, Heterologous vaccine) · Toxoid · Subunit/component/Virus-like particle · Conjugate vaccine · DNA vaccination
Administration Global: GAVI Alliance · Policy · Schedule · Vaccine injury USA: ACIP · VAERS · VSD · Vaccine court
Vaccines
Bacterial

Anthrax · Brucellosis · Cholera# · Diphtheria# · Hib# · Meningococcus# (NmVac4-A/C/Y/W-135, NmVac4-A/C/Y/W-135 - DT, MeNZB) · Pertussis# · Plague · Pneumococcal# (PPSV, PCV) · Tetanus# · Tuberculosis (BCG)# · Typhoid# (Ty21a, ViCPS) · Typhus

combination: DTwP/DTaP
Viral

Adenovirus · Tick-borne encephalitis · Japanese encephalitis# · Flu# (Pandemrix, LAIV, H1N1) · HAV# · HBV# · HPV (Gardasil, Cervarix) · Measles# · Mumps# (Mumpsvax) · Polio# (Salk, Sabin) · Rabies# · Rotavirus# · Rubella# · Smallpox (Dryvax) · Varicella (chicken pox)# · Yellow fever# combination: MMR · MMRV

research: Cytomegalovirus · Epstein-Barr · HIV · Hepatitis C
Protozoan Malaria · Trypanosomiasis
Helminthiasis Schistosomiasis · Hookworm
Other TA-CD · NicVAX · Cancer vaccines (ALVAC-CEA vaccine)
Controversy General · MMR · NCVIA · Pox party · Simpsonwood · Thiomersal
See also List of vaccine topics · Epidemiology · Eradication of infectious diseases
#WHO-EM. Withdrawn from market. CLINICAL TRIALS: Phase III. §Never to phase III

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Biomedical research: Study designs / Design of experiments
Overview

Clinical trial · Clinical trial protocol · Clinical trial management · Academic clinical trials · Study design

Controlled study (EBM I to II-1; A to B)

Randomized controlled trial (Blind experiment, Open-label trial)

Observational study (EBM II-2 to II-3; B to C)

Cross-sectional study vs. Longitudinal study, Ecological study Cohort study (Retrospective cohort study, Prospective cohort study) Case-control study (Nested case-control study) Case series · Case study / Case report

Epidemiology/ methods

occurrence: Incidence (Cumulative incidence) · Prevalence (Point prevalence, Period prevalence) association: absolute (Absolute risk reduction, Attributable risk, Attributable risk percent) · relative (Relative risk, Odds ratio, Hazard ratio) other: Virulence · Infectivity · Mortality rate · Morbidity · Case fatality · Specificity and sensitivity · Likelihood-ratios

Trial/test types

In vitro / In vivo · Animal testing · Animal testing on non-human primates · First-in-man study · Multicenter trial · Seeding trial · Vaccine trial

Analysis of clinical trials

Risk-benefit analysis

Interpretation of results

Selection bias · Correlation does not imply causation · Null result

Category · Glossary · List of topics

External links

Categories: Virology | Microbiology | Immunology | Vaccination | Clinical research

 

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