Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules

Completed · Phase 4

Conditions studied: Rotavirus Infection

In brief

Rotavirus, sometimes called the "stomach flu," is the most common cause of severe diarrhea in children. Vaccines can prevent many types of infections and work by causing the body to make proteins called antibodies that fight infection. For some vaccines, more than one vaccination is needed so that the body will make enough antibodies to fight infection. The vaccines (RotaTeq® or Rotarix® oral vaccines) given in this study are recommended for infants by the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP). These vaccines require either 2 or 3 vaccinations to be effective. Healthy infants between 6 weeks and 14 weeks, 6 days of age at Visit 1 will participate for about 10-12 months. Study procedures include reaction assessment and blood sample.

Key facts

Study ID

NCT01266850

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

1384

Starts

2011-03-01

Expected to finish

2014-03-01

Last updated by the study team

2014-10-28

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female infants who are at least 6 weeks of age and no more than 14 weeks, 6 days of age at Visit 1.
• Parent(s)/legal guardian(s) have signed informed consent documents.
• Children who will be available for the entire study period and whose parents/legal guardians can be reached by telephone.
• Healthy infants as determined by medical history and by a baseline physical examination with no clinically significant abnormal findings within 14 days before the first dose.
• Parents/legal guardians able to complete all relevant study procedures during study participation.

You may not qualify if…

• Any clinically significant history of gastrointestinal disease including abdominal surgery or liver disease or other serious medical conditions as determined by the site investigator.
• Any history of immunodeficiency in the infant (e.g., the infant is known to be human immunodeficiency virus (HIV) positive, to have hypogammaglobulinemia, or to have an underlying malignancy), or any infant with any unvaccinated household contact who is immunocompromised such as:
• Any malignancies or are otherwise immunocompromised;
• Primary immunodeficiency; or
• Receiving immunosuppressive therapy.
• Known sensitivity to any vaccine components, such as latex in the Rotarix® applicator.
• Previous receipt of a rotavirus vaccine.
• Acute illness at the time of vaccine administration, such as any of the following within the past 48 hours:
• Axillary temperature of 100.4 degrees Fahrenheit or higher, or
• More than 3 grossly watery stools, or
• Any episodes of vomiting (forceful expulsion of partially digested milk/food). Infants with previous diagnoses of gastroesophageal reflux whose regurgitation episodes have not changed in the 48-hour period prior to the first vaccination may be enrolled.
• If these symptoms clear within 48 hours and the subject meets the other inclusion/exclusion criteria, then the subject may be enrolled.
• The subject is currently participating in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication) or has received an experimental agent within 1 month prior to enrollment in this study, or expects to receive another experimental agent during participation in this study.
• Less than 37 weeks gestation at birth.
• Receipt of blood and/or blood products (including immunoglobulin) within 4 weeks before vaccine administration.
• Receipt of live vaccine within the past 30 days or a nonreplicating, inactivated, or subunit vaccine within the last 14 days, although planned licensed trivalent inactivated influenza vaccine that may be administered to children over 6 months of age during a routine clinic visit is permitted and would not be exclusionary.
• The subject has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

Where it is running

• Kaiser Permanente Vaccine Study Center — Oakland, California, United States
• Children's Hospital & Research Center Oakland - Primary Care Clinic — Oakland, California, United States
• Emory Children's Center - Pediatric Infectious Diseases — Atlanta, Georgia, United States
• University of Iowa - Vaccine Research & Education Unit — Iowa City, Iowa, United States
• University of Maryland School of Medicine - Center for Vaccine Development - Baltimore — Baltimore, Maryland, United States
• Children's Mercy Hospital and Clinics - Infectious Diseases — Kansas City, Missouri, United States
• Duke Translational Medicine Institute - Clinical Vaccine Unit — Durham, North Carolina, United States
• Primary Physicians Research Inc. - Pittsburgh — Pittsburgh, Pennsylvania, United States
• Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center — Nashville, Tennessee, United States
• The University of Texas Medical Branch - Sealy Center for Vaccine Development (SCVD) — Galveston, Texas, United States
• Baylor College of Medicine - Molecular Virology and Microbiology — Houston, Texas, United States
• Group Health Research Institute - Seattle — Seattle, Washington, United States
• Seattle Children's Hospital - Infectious Diseases — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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