Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Dec 23, 2010

Keywords

ClinConnect Summary

Rotavirus is the most common cause of severe gastroenteritis among children. The purpose of the proposed study is to determine the non-inferiority and safety of the 2 licensed rotavirus vaccines when both are administered to the same child during sequential vaccinations. Both Rotarix® and RotaTeq® vaccines have been evaluated for safety and efficacy in placebo-controlled trials with more than 70,000 infants each and it is likely that both vaccines delivered in various combinations will be safe and effective. Since RotaTeq® was licensed in the United States (US) in 2006, approximately 6 mill...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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:
• • 1. Axillary temperature of 100.4 degrees Fahrenheit or higher, or
• • 2. More than 3 grossly watery stools, or
• • 3. 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.