An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq) (NCT01960725) | Clinical Trial Compass
CompletedPhase 4
An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq)
United States66 participantsStarted 2014-02
Plain-language summary
This is a pilot study to assess the safety and immunogenicity of pentavalent rotavirus vaccine (RV5) when administered according to an alternate dosing schedule (2-5 weeks, 2 months and 4 months). In this interventional, open-label study, infants 2 through 5 weeks of age (14 to 41 days) will be enrolled and vaccinated with RV5 according to a 2-5 week, 2 and 4 month schedule and infants 2 months of age (56 to 83 days) will be vaccinated according to the standard recommended schedule (2, 4, and 6 months of age). Sera will be obtained from subjects one month following the final dose of vaccine and will be assayed for anti-rotavirus IgA and rotavirus neutralizing antibody responses against the G1, G2, G3, G4 and P\[8\] serotypes. Post dose 3 G1 serum-neutralizing antibody (SNA) geometric mean titers (GMTs) will be compared between children receiving pentavalent rotavirus vaccine (RV5) according to the alternate dosing schedule versus the standard recommended schedule. Likewise, post dose 3 G2, G3, G4 and P\[8\] SNA and serum rotavirus IgA GMTs will be compared between children receiving RV5 according to the alternate dosing schedule and the standard recommended schedule. The safety and tolerability of RV5 in children receiving vaccine according to the alternate dosing schedule will be described.
Who can participate
Age range14 Days – 83 Days
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female infants who are 14 through 41 or 56 through 83 days of age at Visit 1 (Day of initial vaccination)
✓. Parent / legal guardian has read and signed the informed consent document
✓. Child and parent / legal guardian is available for the entire study period and can be reached by telephone
✓. Healthy infant as determined by medical history and by a baseline physical examination
✓. Infant weight at time of enrollment must exceed birth weight
Exclusion criteria
✕. History of hypersensitivity to the vaccine or any component of the vaccine
✕. History of Severe Combined Immunodeficiency Disease (SCID)
✕. History of immunocompromise ( infant is known to be HIV positive, to have hypogammaglobulinemia or to have an underlying malignancy)
✕. History of intussusception
What they're measuring
1
G1 Serum-neutralizing Antibody
Timeframe: 1 month following vaccine series completion
. Any clinically significant history of gastrointestinal disease including active acute gastrointestinal illness, chronic diarrhea, failure to thrive, congenital abdominal disorders, abdominal surgery or liver disease
✕. Prior receipt of a rotavirus vaccine
✕. Less than 37 weeks gestation
✕. The subject has participated in a study with an experimental agent within one month of enrollment in the study or anticipated receipt of an experimental agent during participation in the study