NCT01266850

Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules With RotaTeq® and Rotarix®

Completed Phase 4 Results posted Last updated 23 October 2014

What this trial tests

Phase 4 trial testing Rotarix® in Rotavirus Infection in 1,384 participants. Completed in 1 March 2014.

Timeline

1 March 2011

Primary endpoint
1 October 2013

1 March 2014

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1,384
Start date	1 March 2011
Primary completion	1 October 2013
Estimated completion	1 March 2014
Sites	13 locations across United States

Drugs / interventions tested

• Rotarix®
• RotaTeq®

Conditions studied

• Rotavirus Infection — all drugs for Rotavirus Infection →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 6 Weeks to 14 Weeks, any sex, with Rotavirus Infection. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the WC3 IgA Assay
  Time frame: 3-6 weeks after the last vaccination
  Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the anti-rotavirus IgA antibody titer. A participant met the threshold of a positive response if the post vaccination anti-rotavirus IgA antibody titer was 20 or greater.
• Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the 89-12 IgA Assay
  Time frame: 3-6 weeks after the last vaccination
  Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA 89-12 assay to determine the anti-rotavirus IgA antibody titer. A participant met the threshold of a positive response if the post vaccination anti-rotavirus IgA antibody titier was 20 or greater.
• Geometric Mean Serum Anti-rotavirus IgA Titer
  Time frame: 3-6 weeks after the last dose of vaccine
  Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the anti-rotavirus IgA antibody titers. The geometric mean titers (GMT) for each group were calculated along with the 95% confidence intervals.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules.
   Libster R, McNeal M, Walter EB, Shane AL, et al · · 2016 · cited 25× · PMID 26823540 · DOI 10.1542/peds.2015-2603
2. Association between mixed rotavirus vaccination types of infants and rotavirus acute gastroenteritis.
   Mohammed A, Immergluck L, Parker TC, Jain S, et al · · 2015 · cited 6× · PMID 26322843 · DOI 10.1016/j.vaccine.2015.08.027
3. 2280. Antibiotic Exposure Does Not Impact Serological Responses to Rotavirus Vaccination
   Anderson E, Lopman B, Yi J, Yildirim I, et al · · 2018
4. 2278. Maternal Immunization Rates With Tetanus–Diphtheria–Acellular Pertussis and Influenza Vaccines in the United States: A Retrospective Claims Database Analysis
   Ghaswalla P, Poirrier J, Packnett E, Irwin D, et al · · 2018
5. 2279. A Randomized Open-Label Trial of 2-Dose or 3-Dose Primary Rabies Immunization Among Thai Children
   Janewongwirot P. · · 2018