An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS), Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2014 |
| End Date: | June 2016 |
An Open-label, Pilot Study to Compare the Safety and Immunogenicity of an Alternate Dosing Schedule (2-5 Weeks, 2 Months, and 4 Months) for Pentavalent Rotavirus Vaccine (RotaTeq) to the Standard Recommended Schedule (2, 4, and 6 Months)
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.
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.
Inclusion Criteria:
1. Male or female infants who are 14 through 41 or 56 through 83 days of age at Visit 1
(Day of initial vaccination)
2. Parent / legal guardian has read and signed the informed consent document
3. Child and parent / legal guardian is available for the entire study period and can be
reached by telephone
4. Healthy infant as determined by medical history and by a baseline physical
examination
5. Infant weight at time of enrollment must exceed birth weight
Exclusion Criteria:
1. History of hypersensitivity to the vaccine or any component of the vaccine
2. History of Severe Combined Immunodeficiency Disease (SCID)
3. History of immunocompromise ( infant is known to be HIV positive, to have
hypogammaglobulinemia or to have an underlying malignancy)
4. History of intussusception
5. 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
6. Prior receipt of a rotavirus vaccine
7. Less than 37 weeks gestation
8. 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
9. Receipt of blood products within 4 weeks of study vaccination
10. Receipt of a live virus vaccine within 4 weeks of study vaccination or an inactivated
vaccine within 2 weeks. Concomitant administration of routinely recommended vaccines
is allowed. A dose of hepatitis B vaccine administered in the birthing hospital is
permitted. Planned routine use of inactivated influenza vaccine for children over 6
months of age is permitted.
11. Acute illness within 48 hours of vaccination (axillary temperature of 100.4°F or
higher, 3 or more grossly watery stools, vomiting). (Infants with stable unchanged
gastroesophageal reflux may be enrolled).
12. Insufficient weight gain requiring future weight checks in addition to routine
scheduled well child visits
13. The subject has any condition that the investigator believes would put the subject at
an increased risk of injury or would render the subject unable to complete the trial
or fulfill the requirements of the study protocol.
14. Household contact who is immunodeficient (any malignancies or otherwise
immunocompromised, primary immunodeficiency, receiving immunosuppressive therapy)
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