Phase 3
Completed N=1,020
A Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035)
Rotavirus Gastroenteritis
Source: ClinicalTrials.gov NCT01600092 ↗
Enrolled (actual)
1,020
Serious AEs
3.2%
Results posted
Mar 2015
Primary outcomePrimary: Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] — 99.8; 106.1; 30.0; 26.3 Titer
Summary
A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™ with the existing formulation in infants. The primary hypothesis of the study is that the new formulation will be noninferior to the existing formulation on the basis of immunogenicity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] |
99.8; 106.1; 30.0; 26.3; 82.8; 25.2 | — |
| SECONDARY Number of Participants With Tier-1 Adverse Events: Diarrhea, Vomiting, Elevated Temperature, and Irritability |
144; 128; 84; 92; 217; 223 | — |
| SECONDARY Number of Participants With Tier-1 Adverse Events: Intussusception |
2; 0 | — |
| SECONDARY Geometric Mean Titer of Serum Anti-Rotavirus Immunoglobulin A |
240.5; 235.5 | — |
| SECONDARY Percentage of Participants With >=3-fold Rise From Baseline in GMT of Serum Neutralizing Antibody to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] |
56.0; 53.8; 30.4; 26.8; 65.8; 33.3 | — |
Eligibility Criteria
Inclusion Criteria
- Parent or legal guardian agrees to have infant participate by giving written informed consent
Exclusion Criteria
- History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery
- History of intussusception
- Known or suspected impairment of immunological function, including Severe
Combined Immunodeficiency (SCID)
- Prior administration of any rotavirus vaccine
- Clinical evidence of active gastrointestinal illness, with the exception of well-controlled gastroesophageal reflux disease (GERD)
- Receipt of 1) systemic corticosteroids (≥ 2mg/kg total daily dose of prednisone or equivalent) for 14 consecutive days or more since birth, or 2) systemic corticosteroids ≥ 2mg/kg/dose within 7 days prior to the administration of the first dose of study vaccine. Participant using non-systemic corticosteroids will be eligible for vaccination.
- Residing in a household with an immunocompromised person
- Prior receipt of a blood transfusion or blood products, including immunoglobulins
- Participation in another interventional study within 14 days prior to the first study vaccination or expected anytime during the study
- Receipt of investigational inactivated vaccines within 14 days or investigational live vaccines within 28 days prior to the first study vaccination or expected anytime during the study
Data sourced from ClinicalTrials.gov (NCT01600092). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.