Phase 3
Completed N=110
Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India (V260-021)
Source: ClinicalTrials.gov NCT00496054 ↗Enrolled (actual)
110
Serious AEs
1.0%
Results posted
Mar 2010
Primary outcomePrimary: The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA — 82.35 Percentage of Participants
Summary
To observe the safety, tolerability and immunogenicity of the administration of 3 doses of rotateq in healthy Indian infants between 6 weeks through exactly 12 weeks of age at entry.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA |
82.83 | — |
| PRIMARY The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies (SNA) |
38.24 | — |
| PRIMARY The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA) |
14.14 | — |
| PRIMARY The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA) |
29.29 | — |
| PRIMARY The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA) |
35.35 | — |
| PRIMARY The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA) |
29.29 | — |
| PRIMARY The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies(SNA) |
37.37 | — |
| PRIMARY The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA |
3.68; 75.12 | — |
| PRIMARY The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1 |
43.11; 81.19 | — |
| PRIMARY The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2 |
62.91; 49.21 | — |
| PRIMARY The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3 |
27.71; 32.95 | — |
| PRIMARY The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4 |
51.74; 80.88 | — |
| PRIMARY The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1 |
84.17; 100.01 | — |
Eligibility Criteria
Inclusion Criteria
- Age 6 weeks through exactly 12 weeks
- Healthy infants
Exclusion Criteria
- Clinical evidence of active gastrointestinal illness
- Fever, with a rectal temperature of greater than and equal to thirty eight degree celsius at the time of immunization
- History of congenital abdominal disorders, intussusception, or abdominal surgery
- History of known prior rotavirus disease
- Known or suspected impairment of immunological function
- Prior administration of any rotavirus vaccine
- Known hypersensitivity to any component of the rotavirus vaccine, e.g. trypsin
Data sourced from ClinicalTrials.gov (NCT00496054). 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.