Double-Blind, Placebo-Controlled, Randomized Trials

Have you been told that there are no double-blind, placebo-controlled, randomized trials on vaccines? That is untrue. Here is a list of many such studies!

Note: Once there is an effective vaccine, future development of newer vaccines for the same antigen do not get compared to a placebo. They get compared in studies to the prior version of the vaccine. This is so that half of the population in the study does not need to remain exposed to preventable diseases.

Englund, J. A., Walter, E., Black, S., Blatter, M., Nyberg, J., Ruben, F. L., … & GRC28 Study Team. (2010). Safety and immunogenicity of trivalent inactivated influenza vaccine in infants: a randomized double-blind placebo-controlled study. The Pediatric infectious disease journal, 29(2), 105-110.

Garland, S. M., Ault, K. A., Gall, S. A., Paavonen, J., Sings, H. L., Ciprero, K. L., … & Zhou, H. (2009). Pregnancy and infant outcomes in the clinical trials of a human papillomavirus type 6/11/16/18 vaccine: a combined analysis of five randomized controlled trials. Obstetrics & Gynecology, 114(6), 1179-1188.

Huh, W. K., Joura, E. A., Giuliano, A. R., Iversen, O. E., de Andrade, R. P., Ault, K. A., … & Mayrand, M. H. (2017). Final efficacy, immunogenicity, and safety analyses of a nine-valent human papillomavirus vaccine in women aged 16–26 years: a randomised, double-blind trial. The Lancet, 390(10108), 2143-2159.

Macki, M., & Dabaja, A. A. (2016). Literature review of vaccine-related adverse events reported from HPV vaccination in randomized controlled trials. Basic and clinical andrology, 26(1), 16.

Marshall, H. S., Richmond, P. C., Beeslaar, J., Jiang, Q., Jansen, K. U., Garcés-Sánchez, M., … & Harris, S. L. (2017). Meningococcal serogroup B-specific responses after vaccination with bivalent rLP2086: 4 year follow-up of a randomised, single-blind, placebo-controlled, phase 2 trial. The Lancet Infectious Diseases, 17(1), 58-67.

Muñoz, N., Manalastas Jr, R., Pitisuttithum, P., Tresukosol, D., Monsonego, J., Ault, K., … & Bautista, O. (2009). Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in women aged 24–45 years: a randomised, double-blind trial. The Lancet, 373(9679), 1949-1957.

Omer, S. et al.  (2018) Maternal influenza immunization and prevention of severe clinical pneumonia in young infants: Analysis of randomized controlled trials conducted in Nepal, Mali and South Africa. The Pediatric Infectious Disease Journal: 37(5): 981-989. doi: 10.1097/INF.0000000000001914

Paavonen, J., Jenkins, D., Bosch, F. X., Naud, P., Salmerón, J., Wheeler, C. M., … & de Carvalho, N. S. (2007). Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle vaccine against infection with human papillomavirus types 16 and 18 in young women: an interim analysis of a phase III double-blind, randomised controlled trial. The Lancet, 369(9580), 2161-2170.

Peltola, H., & Heinonen, O. (1986). Frequency of true adverse reactions to measles-mumps-rubella vaccine: a double-blind placebo-controlled trial in twins. The Lancet, 327(8487), 939-942.

Steinhoff, M. et al. (2017) Year-round influenza immunisation during pregnancy in Nepal: a phase 4, randomised, placebo-controlled trial. Lancet Infectious Disease. 17(9): 981–989. doi:10.1016/S1473-3099(17)30252-9

Strijbos, E., Tannemaat, M. R., Alleman, I., de Meel, R. H., Bakker, J. A., van Beek, R., … & Verschuuren, J. J. (2019). A prospective, double-blind, randomized, placebo-controlled study on the efficacy and safety of influenza vaccination in myasthenia gravis. Vaccine, 37(7), 919-925.

Thierry-Carstensen, B., Jordan, K., Uhlving, H. H., Dalby, T., Sørensen, C., Jensen, A. M., & Heilmann, C. (2012). A randomised, double-blind, non-inferiority clinical trial on the safety and immunogenicity of a tetanus, diphtheria and monocomponent acellular pertussis (TdaP) vaccine in comparison to a tetanus and diphtheria (Td) vaccine when given as booster vaccinations to healthy adults. Vaccine, 30(37), 5464-5471.

Treanor, J. J., El Sahly, H., King, J., Graham, I., Izikson, R., Kohberger, R., … & Cox, M. (2011). Protective efficacy of a trivalent recombinant hemagglutinin protein vaccine (FluBlok®) against influenza in healthy adults: a randomized, placebo-controlled trial. Vaccine, 29(44), 7733-7739.

van Doorn, E., Pleguezuelos, O., Liu, H., Fernandez, A., Bannister, R., Stoloff, G., … & Hak, E. (2017). Evaluation of the immunogenicity and safety of different doses and formulations of a broad spectrum influenza vaccine (FLU-v) developed by SEEK: study protocol for a single-center, randomized, double-blind and placebo-controlled clinical phase IIb trial. BMC infectious diseases, 17(1), 241.