Immunogenicity, Safety, and Tolerability of a Hexavalent Vaccine in Infants

Marshall, Gary S.; Adams, Gregory L.; Leonardi, Michael; Petrecz, Maria; Flores, Sheryl; Ngai, Angela; Xu, Jin; Liu, Guanghan; Stek, Jon E.; Foglia, Ginamarie; Lee, Andrew W.

doi:10.1542/peds.2014-4102

Cited by 30 publications

(17 citation statements)

References 17 publications

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“…1 The authors compared national health insurance claims record of 1994-5 (before vaccine was available) and 2006-12. 1 The authors compared national health insurance claims record of 1994-5 (before vaccine was available) and 2006-12.…”

Section: Routine 2-dose Vaccination Led To Substantial Decrease In Chmentioning

confidence: 99%

“…1 The study is ongoing, with 4,000 subjects having received an injection immediately after exposure to the virus. 1 The study is ongoing, with 4,000 subjects having received an injection immediately after exposure to the virus.…”

Section: Rvsv-zebov 100% Efficacious Against Ebolamentioning

confidence: 99%

“…1 The second candidate is a collaborative effort of Inovio and researchers from U.S. and Canada. The first is an engineered antigen based on structural information about viral S glycoprotein.…”

Section: Two Preclinical Successes For Mers Vaccinesmentioning

confidence: 99%

“…1 Researchers applied theoretical models to recent outbreaks in Haiti, Zimbabwe and Guinea and found that singledose vaccination could have prevented 1.1-1.2 times more cases of cholera. 1 Researchers applied theoretical models to recent outbreaks in Haiti, Zimbabwe and Guinea and found that singledose vaccination could have prevented 1.1-1.2 times more cases of cholera.…”

Section: Influenza Vaccination Has An Effect On Elderly Populationmentioning

confidence: 99%

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Human Vaccines & Immunotherapeutics: News

2015

Human Vaccines & Immunotherapeutics

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Section: Routine 2-dose Vaccination Led To Substantial Decrease In Chmentioning

confidence: 99%

Section: Rvsv-zebov 100% Efficacious Against Ebolamentioning

confidence: 99%

Section: Two Preclinical Successes For Mers Vaccinesmentioning

confidence: 99%

Section: Influenza Vaccination Has An Effect On Elderly Populationmentioning

confidence: 99%

See 2 more Smart Citations

Human Vaccines & Immunotherapeutics: News

2015

Human Vaccines & Immunotherapeutics

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“…For example, the NI margin for seroresponse rate of a vaccine is often based on the expected true response rate. The current conventional approach is that a margin of 5% is used when the response rate is above 95% and a margin of 10% is used when the rate is less than 95% (see, eg, Marshall et al). This margin may be significantly lower than the one calculated from the double discounting approach because the seroresponse in placebo group can be very low and close to 0%; therefore, the response rate difference between vaccine and placebo can be large.…”

Section: Introductionmentioning

confidence: 99%

A dynamic power prior for borrowing historical data in noninferiority trials with binary endpoint

Liu

2017

Pharmaceutical Statistics

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SummaryTraditionally, noninferiority hypotheses have been tested using a frequentist method with a fixed margin. Given that information for the control group is often available from previous studies, it is interesting to consider a Bayesian approach in which information is "borrowed" for the control group to improve efficiency. However, construction of an appropriate informative prior can be challenging. In this paper, we consider a hybrid Bayesian approach for testing noninferiority hypotheses in studies with a binary endpoint. To account for heterogeneity between the historical information and the current trial for the control group, a dynamic P value-based power prior parameter is proposed to adjust the amount of information borrowed from the historical data. This approach extends the simple test-then-pool method to allow a continuous discounting power parameter. An adjusted α level is also proposed to better control the type I error. Simulations are conducted to investigate the performance of the proposed method and to make comparisons with other methods including test-then-pool and hierarchical modeling. The methods are illustrated with data from vaccine clinical trials. | INTRODUCTIONWhen designing a clinical trial to evaluate a test treatment, active controls are often considered when placebo treatment becomes unethical, for example, in cases of life-threatening disease and the availability of established therapy. However, the goal may not be to demonstrate superiority of the test treatment over the active control but rather be to show that the test treatment is at least as efficacious as the active control. In this case, a noninferiority (NI) trial is commonly used to show that the effect of the test treatment is within a certain prespecified amount of the effect of the active control. This prespecified quantity, called the NI margin, has to be predetermined and agreed upon by the sponsor and regulatory agencies.For clinical trials with a binary endpoint, response rate is often the primary endpoint for treatment comparison. Assuming that a higher rate represents a better response, an NI hypothesis can be formulated as follows:

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Pediatric Combination Vaccines

Martinón-Torres¹

2017

Pediatric Vaccines and Vaccinations

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Immunogenicity, Safety, and Tolerability of a Hexavalent Vaccine in Infants

Abstract: BACKGROUND: DTaP5-IPV-Hib-HepB is a fully liquid investigational hexavalent vaccine directed against 6 diseases.

Cited by 30 publications

References 17 publications

Human Vaccines & Immunotherapeutics: News

Human Vaccines & Immunotherapeutics: News

A dynamic power prior for borrowing historical data in noninferiority trials with binary endpoint

Pediatric Combination Vaccines

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