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Vaccine-Related Journal Articles

Vaccine Safety: Prelicensure

Prelicensure 2013-2007
Safety and Immunogenicity of a Quadrivalent Inactivated Influenza Vaccine Compared to Licensed Trivalent Inactivated Influenza Vaccines in Adults
Authors: Greenberg DP, Robertson CA, Noss MJ, Blatter MM, Biedenbender R, Decker MD
Source: Vaccine, January 21, 2013, Vol. 31(5):770-6
Integrating Safety and Efficacy Evaluation throughout Vaccine Research and Development
Authors: Curlin G, Landry S, Bernstein J, Gorman RL, et al.
Source: Pediatrics, April 18, 2011
Food and Drug Administration Regulation and Evaluation of Vaccines
Authors: Marshall V, Baylor NW
Source: Pediatrics, April 18, 2011
Abstract  |  Full article
Ensuring the Optimal Safety of Licensed Vaccines: A Perspective of the Vaccine Research, Development, and Manufacturing Companies
Authors: Kanesa-Thasan N, Shaw A, Stoddard JJ, Vernon TM
Source: Pediatrics, April 18, 2011
Abstract  |  Full article
Statistical, Epidemiological, and Risk-Assessment Approaches to Evaluating Safety of Vaccines throughout the Life Cycle at the Food and Drug Administration
Authors: Ball R, Horne D, Izurieta H, Sutherland A, Walderhaug M, Hsu H
Source: Pediatrics, April 18, 2011
Abstract  |  Full article
Guidelines for Collection, Analysis and Presentation of Vaccine Safety Data in Pre- and Post-Licensure Clinical Studies
Authors: Bonhoeffer J, Bentsi-Enchill A, Chen RT, et al.
Source: Vaccine, December 1, 2008
Safety and Immunogenicity of Early Vaccination with Two Doses of Tetravalent Measles-Mumps-Rubella-Varicella (MMRV) Vaccine in Healthy Children From 9 Months of Age
Authors: Goh P, Lim FS, Han HH, Willems P
Source: Infection, August 2007 [Epub ahead of print]
Safety and Immunogenicity of a Zoster Vaccine in Varicella-Zoster Virus Seronegative and Low-Seropositive Healthy Adults
Authors: Macaladad N, Marcano T, Guzman M, et al
Source: Vaccine, March 1, 2007; 25(11):2139-2144
Safety and Tolerability of a High-Potency Zoster Vaccine in Adults >/= 50 or Years of Age
Authors: Tyring SK, Diaz-Mitoma F, Padget LG, et al
Source: Vaccine, February 26 2007; 25(10):1877-1883
Safety, Immunogenicity and Efficacy of Modified Vaccinia Ankara (MVA) against Dryvax Challenge in Vaccinia-Naive and Vaccinia-Immune Individuals
Authors: Parrino J, McCurdy LH, Larkin BD, et al
Source: Vaccine, February 9, 2007; 25(8):1513-1525
Efficacy, Immunogenicity, and Safety of a Pentavalent Human-Bovine (WC3) Reassortant Rotavirus Vaccine at the End of Shelf Life
Authors: Block SL, Vesikari T, Goveia MG, et al
Source: Pediatrics, January 2007; 119:11-18
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Prelicensure 2006
Safety of Trivalent Inactivated Influenza Vaccine in Children 6 to 23 Months Old
Authors: Hambidge SJ, Glanz JM, France EK, et al
Source: JAMA, October 25, 2006; 296(16):1990-1997
Comparison of the Efficacy and Safety of Live Attenuated Cold-Adapted Influenza Vaccine, Trivalent, with Trivalent Inactivated Influenza Virus Vaccine in Children and Adolescents with Asthma
Authors: Fleming DM, Crovari P, Wahn U, et al
Source: Pediatr Infect Dis J, October 2006, Vol. 25(10):860-869
A Randomized, Double-Blind Study of the Safety, Transmissibility and Phenotypic and Genotypic Stability of Cold-Adapted Influenza Virus Vaccine
Authors: Vesikari T, Karvonen A, Korhonen T, et al
Source: Pediatr Infect Dis J, July 2006, Vol. 25(7):590-595
Safety of High Doses of Influenza Vaccine and Effect on Antibody Responses in Elderly Persons
Authors: Keitel WA, Atmar RL, Cate TR, et al
Source: Arch Intern Med, May 22, 2006, Vol. 166(10):1121-1127
The Safety of Trivalent Influenza Vaccine Among Healthy Children 6 to 24 Months of Age
Authors: Goodman MJ, Nordin JD, Harper P, DeFor T, Zhou XZ
Source: Pediatrics, May 2006, Vol. 117(5):821-826
Immunogenicity, Reactogenicity and Safety of a 7-valent Pneumococcal Conjugate Vaccine (PCV7) Concurrently Administered with a DTPa-HBV-IPV/Hib Combination Vaccine in Healthy Infants
Authors: Knuf M, Habermehl P, Cimino C, et al
Source: Vaccine, March 24, 2006, [Epub ahead of print]
Immunogenicity and Safety of Two Doses of TetravalentMeasles-Mumps-Rubella-Varicella Vaccine in Healthy Children
Authors: Knuf M, Habermehl P, Zepp F, et al
Source: Pediatr Infect Dis J, January 2006, Vol. 25(1):12-18
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Prelicensure 2005
Evaluation of a Quadrivalent Measles, Mumps, Rubella and Varicella Vaccine in Healthy Children
Authors: Shinefield H, Black S, Digilio L, et al
Source: Pediatr Infect Dis J, August 2005, Vol. 24(8):665-669
Combined Tetanus, Diphtheria, and 5-Component Pertussis Vaccine for Use in Adolescents and Adults
Authors: Pichichero ME, Rennels MB, Edwards KM, et al
Source: JAMA, June 2, 2005, [Epub ahead of print]
Comparative Evaluation of Safety and Immunogenicity of Two Dosages of an Oral Live Attenuated Human Rotavirus Vaccine
Authors: Dennehy PH, Brady RC, Halperin SA
Source: Pediatr Infect Dis J, June 2005, Vol. 24(6):481-48
A Vaccine to Prevent Herpes Zoster and Postherpetic Neuralgia in Older Adults
Authors: Oxman MN, Levin MJ, Johnson GR, et al
Source: N Engl J Med, June 2, 2005, Vol. 352(22):2271-2284
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Prelicensure 2004
Technologies That Make Administration of Vaccines Safer
Authors: Clements CJ, Larsen G, Jodar L
Source: Vaccine, May 7, 2004, Vol. 22(15-16):2054-2058
A Global Perspective on Vaccine Safety
Author: Duclos P
Source: Vaccine, May 7, 2004, Vol. 22(15-16):2059-2063
Ethical Aspects of the Methods Used to Evaluate the Safety of Vaccines
Author: Spier RE
Source: Vaccine, May 7, 2004, Vol. 22(15-16):2085-2090
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Prelicensure 2002
Development of Pediatric Vaccine Recommendations and Policies
Authors: Pickering LK, Orenstein WA
Source: Seminars in Pediatric Infectious Diseases, July 2002, Vol. 13(3):148-154
Vaccination with Measles, Mumps, and Rubella Vaccine and Varicella Vaccine: Safety, Tolerability, Immunogenicity, Persistence of Antibody and Duration of Protection Against Varicella in Healthy Children
Authors: Shinefield HR, Black SB, Staehle BO, et al
Source: Pediatric Infectious Disease Journal, June 2002, Vol. 21(6):555-6
Lack of Consistent Relationship between Quantity of Aluminum in Diphtheria-Tetanus-Acellular Pertussis Vaccines and Rates of Extensive Swelling Reactions
Authors: Rennels M, Deloria M, Pichichero M, et al
Source: Vaccine, May 31, 2002, Vol. 20 (S3):S44-S47
This page was updated on February 22, 2016.
This page was reviewed on January 27, 2016.
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