Effectiveness of Maternal Immunization With Boostrix at Preventing Pertussis Among Infants <2 Months Old in the United States: Analysis of a Dataset From a Case-control Study
Conditions: Whooping Cough
Sponsor: GlaxoSmithKline

24 June 2020 
 
 
STATEMENT FOR STUDY PROTOCOL AVAILABILITY 
 
Detailed Title: 
Effectiveness of maternal immunization with Boostrix at 
preventing pertussis among infants <2 Months old in the United 
States: analysis of a dataset from a case-control study 
conducted by the Centre for Disease Control. 
eTrack study number and 
Abbreviated Title: 
210031 (EPI-PERTUSSIS-052 VE US DB) 
Statement for study 
protocol availability: 
 
The initial study on the effectiveness of Tdap maternal 
immunization at preventing pertussis in infants was conducted 
by the Emerging Infections Program Network. This is a 
collaborative network between the Centers for Disease Control 
and Prevention and state and local health departments, 
academic institutions, and laboratories that serves as a national 
resource for surveillance, prevention, and control of emerging 
infectious diseases. The results of this study have been 
published in Clinical Infectious Diseases in 2017 (Skoff TH, 
Blain AE, Watt J, Scherzinger K, McMahon M, Zansky SM, 
Kudish K, Cieslak PR, Lewis M, Shang N, Martin SW. Impact 
of the US Maternal Tetanus, Diphtheria, and Acellular 
Pertussis Vaccination Program on Preventing Pertussis in 
Infants <2 Months of Age: A Case-Control Evaluation. 
PMID:29028938). 
Within the frame of a data use agreement, GSK performed a 
brand-specific post-hoc analysis of a limited data set to estimate 
the effectiveness of the Boostrix Tdap vaccine. Considering the 
specificities of this project, developing both a protocol and a 
statistical analysis plan would have been redundant and of no 
added value. GSK therefore described the planned analysis in a 
single document, which was a detailed statistical analysis plan. 
Date of Statement: 
24 June 2020