Adapting Group Sequential Methods to Observational Postlicensure Vaccine Safety Surveillance: Results of a Pentavalent Combination DTaP-IPV-Hib Vaccine Safety Study

Statistical performance of group sequential methods for observational post-licensure medical product safety surveillance: A simulation study

(2013) Andrea Cook et al.   Statistics and Its Interface

Challenges in the design and analysis of sequentially monitored postmarket safety surveillance evaluations using electronic observational health care data

(2012) Jennifer C. Nelson et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

H1N1 and Seasonal Influenza Vaccine Safety in the Vaccine Safety Datalink Project

(2011) Grace M. Lee et al.   AMERICAN JOURNAL OF PREVENTIVE MEDICINE

Developing the Sentinel System — A National Resource for Evidence Development

(2011) Rachel E. Behrman et al.   NEW ENGLAND JOURNAL OF MEDICINE

Active Surveillance for Adverse Events: The Experience of the Vaccine Safety Datalink Project

(2011) W. K. Yih et al.   PEDIATRICS

The Vaccine Safety Datalink: A Model for Monitoring Immunization Safety

(2011) J. Baggs et al.   PEDIATRICS

Near real-time vaccine safety surveillance with partially accrued data

(2011) Sharon K. Greene et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Monitoring the safety of quadrivalent human papillomavirus vaccine: Findings from the Vaccine Safety Datalink

(2011) Julianne Gee et al.   VACCINE

A Maximized Sequential Probability Ratio Test for Drug and Vaccine Safety Surveillance

(2011) Martin Kulldorff et al.   Sequential Analysis-Design Methods and Applications

Measles-Mumps-Rubella-Varicella Combination Vaccine and the Risk of Febrile Seizures

(2010) N. P. Klein et al.   PEDIATRICS

Sequential generalized likelihood ratio tests for vaccine safety evaluation

(2010) Mei-Chiung Shih et al.   STATISTICS IN MEDICINE

Immunogenicity and safety of a combined diphtheria, tetanus, 5-component acellular pertussis, inactivated poliomyelitis, Haemophilus type b conjugate vaccine when administered concurrently with a pneumococcal conjugate vaccine: A randomized, open-label, phase 3 study

(2010) Henry H. Bernstein et al.   VACCINE

Real-Time Surveillance to Assess Risk of Intussusception and Other Adverse Events After Pentavalent, Bovine-Derived Rotavirus Vaccine

(2009) Edward A. Belongia et al.   PEDIATRIC INFECTIOUS DISEASE JOURNAL

Observational safety study of febrile convulsion following first dose MMRV vaccination in a managed care setting

(2009) Steven J. Jacobsen et al.   VACCINE

An assessment of the safety of adolescent and adult tetanus–diphtheria–acellular pertussis (Tdap) vaccine, using active surveillance for adverse events in the Vaccine Safety Datalink

(2009) W. Katherine Yih et al.   VACCINE

Safety and Immunogenicity of a Pentavalent Vaccine Compared With Separate Administration of Licensed Equivalent Vaccines in US Infants and Toddlers and Persistence of Antibodies Before a Preschool Booster Dose: A Randomized, Clinical Trial

(2008) F. A. Guerra et al.   PEDIATRICS