Related Experiment Video

Updated: Jul 7, 2026

Experimental Human Pneumococcal Carriage
07:47

Experimental Human Pneumococcal Carriage

Published on: February 15, 2013

Design of a group-randomized Streptococcus pneumoniae vaccine trial

L H Moulton1, K L O'Brien, R Kohberger

  • 1The Center for American Indian and Alaskan Native Health, Department of International Health, The Johns Hopkins University School of Hygiene and Public Health, Baltimore, MD 21205, USA. lmoulton@jhsph.edu

Controlled Clinical Trials
|August 22, 2001
PubMed

Insights

This study evaluated a Streptococcus pneumoniae conjugate vaccine in American Indian infants. The group-randomized trial assessed vaccine efficacy and herd immunity in southwestern US communities.

Area of Science:

  • Clinical Trials
  • Vaccinology
  • Epidemiology

Background:

  • Streptococcus pneumoniae causes significant invasive pneumococcal disease (IPD) globally.
  • Vaccine development is crucial for preventing IPD, especially in vulnerable populations.
  • Group-randomized trials offer unique insights into community-level interventions.

Purpose of the Study:

  • To determine the efficacy of a Streptococcus pneumoniae conjugate vaccine in infants.
  • To evaluate the impact of the vaccine on invasive pneumococcal disease incidence.
  • To assess indirect effects, including herd immunity, within American Indian communities.

Main Methods:

  • A phase III, double-masked, group-randomized trial involving approximately 9000 infants.
  • Vaccine allocation was determined by community of residence across 38 randomized areas.
  • The trial continued until 48 cases of IPD due to vaccine serotypes were observed.

Main Results:

  • The study design allows for the estimation of vaccine effectiveness against IPD.
  • It also enables the assessment of indirect protection conferred to unvaccinated individuals.
  • This trial represents a pioneering group-randomized study seeking drug licensure in the US.

Conclusions:

  • Group-randomized trials are feasible for evaluating vaccine efficacy and community impact.
  • The findings will inform public health strategies for pneumococcal disease prevention.
  • This research contributes valuable data on vaccine effectiveness in a specific population.

More Related Videos

Capsular Serotyping of Streptococcus pneumoniae by Latex Agglutination09:11

Capsular Serotyping of Streptococcus pneumoniae by Latex Agglutination

Published on: September 25, 2014

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition04:53

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

Related Concept Videos

Group Design02:01

Group Design

The most basic experimental design involves two groups: the experimental group and the control group. The two groups are designed to be the same except for one difference— experimental manipulation. The experimental group gets the experimental manipulation—that is, the treatment or variable being tested—and the control group does not. Since experimental manipulation is the only difference between the experimental and control groups, we can be sure that any differences between the two are due to...
Study Design in Statistics01:15

Study Design in Statistics

A study design is a set of techniques that allow a researcher to collect and analyze data from different variables defined for a specific research problem. Statistics is commonly for effective study design and more robust experiments,
Does aspirin reduce the risk of heart attacks? Is one brand of fertilizer more effective at growing roses than another? Is fatigue as dangerous to a driver as the influence of alcohol? Questions like these are answered using randomized experiments with proper...
Randomized Experiments01:13

Randomized Experiments

The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
Simple...
Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs01:20

Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs

Bioequivalence experimental study designs are crucial methodologies used in evaluating and comparing the bioavailability of different drug products. These designs are categorized into various types: completely randomized, randomized block, repeated measures, cross and carry-over, and Latin square designs.Completely randomized designs involve randomly allocating treatments to all subjects participating in the experiment. This allocation is achieved by assigning unique random numbers to subjects...
Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs01:15

Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs

Bioequivalence experimental study designs play a pivotal role in testing the effectiveness of various treatments. Key among these are the repeated measures, cross-over, carry-over, and Latin square designs. In the repeated measures design, each subject receives all treatments, allowing for temporal comparisons. This type of design is useful in reducing variability but requires careful planning to avoid bias.The cross-over design, an economical method, involves sequential administration of...
Study Designs in Epidemiology01:20

Study Designs in Epidemiology

Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and case-control studies.