H2O-
Glad you found it interesting. As far as was the placebo inert, yes it was. Was safety addressed- it was, both in the full text of this article, and in a subsequent paper that focused on long-term safety. Not everything can make it into one paper, since they are usually fairly strict on word limits of 3-4,000 words.
As far as are those results significant clinically, as a clinician I'd say highly significant. Zoster causes fairly debilitating pain in a large proportion of people, and there are other complications such as encephalitis (I have a guy with that in the hospital right now). And I would say 3.3% incidence in the unvaccinated group is not rare, especially in a 3 year period.
As far as such studies being rare, and hard to find, no, they really are not. And I don't mean to sound too negative, but really the fact that you couldn't find this speaks to either lack of effort or lack of knowing how to go about looking for evidence. If you walked into the library at any university and asked the librarian for a few minutes of help, they would find this. It's not like it was hidden, the New England Journal is the premier medical journal in the US, if not the world, and their site is searchable (nejm.org).
Other similar studies do exist, and again, the fact that you did not find them says more about the effort/search strategy, versus the studies not existing. Here is just a sample:
N Engl J Med. 2003 Oct 2;349(14):1341-8.
A trial of a 9-valent pneumococcal conjugate vaccine in children with and those without HIV infection.
Klugman KP, Madhi SA, Huebner RE, Kohberger R, Mbelle N, Pierce N; Vaccine Trialists Group.
Medical Research Council, University of the Witwatersrand, National Institute for Communicable Diseases, Respiratory and Meningeal Pathogens Research Unit, Johannesburg, South Africa.
kklugma@sph.emory.edu
Abstract
BACKGROUND: Acute respiratory tract infections caused by Streptococcus pneumoniae are a leading cause of morbidity and mortality in young children. We evaluated the efficacy of a 9-valent pneumococcal conjugate vaccine in a randomized, double-blind study in Soweto, South Africa. METHODS: At 6, 10, and 14 weeks of age, 19,922 children received the 9-valent pneumococcal polysaccharide vaccine conjugated to a noncatalytic cross-reacting mutant of diphtheria toxin (CRM197), and 19,914 received placebo. All children received Haemophilus influenzae type b conjugate vaccine. Efficacy and safety were analyzed according to the intention-to-treat principle. RESULTS: Among children without human immunodeficiency virus (HIV) infection, the vaccine reduced the incidence of a first episode of invasive pneumococcal disease due to serotypes included in the vaccine by 83 percent (95 percent confidence interval, 39 to 97; 17 cases among controls and 3 among vaccine recipients). Among HIV-infected children, the efficacy was 65 percent (95 percent confidence interval, 24 to 86; 26 and 9 cases, respectively). Among children without HIV infection, the vaccine reduced the incidence of first episodes of radiologically confirmed alveolar consolidation by 20 percent (95 percent confidence interval, 2 to 35; 212 cases in the control group and 169 in the vaccinated group) in the intention-to-treat analysis and by 25 percent (95 percent confidence interval, 4 to 41; 158 and 119 cases, respectively) in the per-protocol analysis (i.e., among fully vaccinated children). The incidence of invasive pneumococcal disease caused by penicillin-resistant strains was reduced by 67 percent (95 percent confidence interval, 19 to 88; 21 cases in the control group and 7 in the vaccinated group), and that caused by strains resistant to trimethoprim-sulfamethoxazole was reduced by 56 percent (95 percent confidence interval, 16 to 78; 32 and 14 cases, respectively). CONCLUSIONS: Vaccination with a 9-valent pneumococcal conjugate vaccine reduced the incidence of radiologically confirmed pneumonia. The vaccine also reduced the incidence of vaccine-serotype and antibiotic-resistant invasive pneumococcal disease among children with and those without HIV infection. Copyright 2003 Massachusetts Medical Society
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Vaccine. 2009 Dec 11;28(2):345-51. Epub 2009 Oct 29.
RotaTeq, a pentavalent rotavirus vaccine: efficacy and safety among infants in Europe.
Vesikari T, Itzler R, Karvonen A, Korhonen T, Van Damme P, Behre U, Bona G, Gothefors L, Heaton PM, Dallas M, Goveia MG.
University of Tampere Medical School, Tampere, Finland.
timo.vesikari@uta.fi
Abstract
A pentavalent human-bovine reassortant oral rotavirus vaccine, RotaTeq, was evaluated among nearly 70,000 infants in the Rotavirus Efficacy and Safety Trial (REST), of which 30,523 were from Europe. All infants were followed for serious adverse events as well as hospitalizations and emergency department (ED) visits. All adverse events, health care utilization, and RVGE regardless of severity were evaluated in the clinical efficacy cohort (N=2686) in Finland. RotaTeq was 98.3% (95% CI, 90.2-100%) and 68.0% (95% CI 60.3-74.4%) efficacious against severe rotavirus gastroenteritis (RVGE) and all RVGE due to any serotype for two rotavirus seasons post-vaccination. The combined rate of hospitalizations and ED visits due to RVGE of any serotype was reduced by 94.5% (95% CI, 91.3-96.8%) for up to 2 years after vaccination. There were no statistically significant differences between RotaTeq and placebo for any of the safety outcomes. In Europe, RotaTeq was highly efficacious and well tolerated.