Phase 3
Completed N=4,040
Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024)
Rotavirus Gastroenteritis
Source: ClinicalTrials.gov NCT02062385 ↗
Enrolled (actual)
4,040
Serious AEs
16.8%
Results posted
Apr 2016
Primary outcomePrimary: Number of Participants With Any Severity of Rotavirus Gastroenteritis — 34; 109 Participants — p=<0.001
◆ Published Evidence
Established
51citations · ~6 / year
Efficacy and safety of a pentavalent live human-bovine reassortant rotavirus vaccine (RV5) in healthy Chinese infants: A randomized, double-blind, placebo-controlled trial.
Summary
This study will assess the efficacy, safety, and immunogenicity of a 3-dose regimen of RotaTeq™ (V260) in healthy Chinese infants. Approximately 4040 participants at least 6 weeks and up to 12 weeks of age at the time of the first vaccination with V260 or placebo will be enrolled and randomized (1:1) to receive either V260 or placebo. Participants will also receive the routine China Expanded Program on Immunization (EPI) vaccines (oral poliovirus vaccine [OPV] and diphtheria, tetanus, and acellular pertussis vaccine [DTaP]) either staggered or concomitantly with V260 or placebo. All participants will be followed for efficacy and safety. Immune responses to OPV and DTaP will be evaluated in a subset of participants. The primary hypothesis of the study states that V260 will be efficacious in preventing any severity of rotavirus gastroenteritis as compared with placebo.
Linked Publications (2)
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Efficacy and safety of a pentavalent live human-bovine reassortant rotavirus vaccine (RV5) in healthy Chinese infants: A randomized, double-blind, placebo-controlled trial.
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Immunogenicity of pentavalent rotavirus vaccine in Chinese infants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Severity of Rotavirus Gastroenteritis |
34; 109 | <0.001 sig |
| SECONDARY Percentage of Participants With Elevated Temperature |
21.84; 22.83 | — |
| SECONDARY Percentage of Participants With Vomiting or Diarrhea |
2.68; 3.52; 20.15; 20.11 | — |
| SECONDARY Percentage of Participants With Intussusception |
0.10; 0.00 | — |
| SECONDARY Number of Participants With Severe Rotavirus Gastroenteritis |
11; 52 | — |
| SECONDARY Percentage of Participants Who Achieved Seroprotection Against Poliovirus Type 1, 2, or 3 |
44.09; 38.95; 98.93; 100.00; 44.09; 41.58 | — |
| SECONDARY Percentage of Participants With Any Adverse Event |
53.5; 53.3 | — |
| SECONDARY Percentage of Participants Seropositive to Diphtheria, Pertussis, or Tetanus Antigens |
3.31; 2.69; 99.47; 99.48; 0.00; 0.00 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy infants at least 6 weeks (42 days) and up to 12 weeks (84 days) of age at the time of the first study vaccination
- Parent/legal guardian agrees to participate by giving written informed consent and is willing and able to comply with study requirements
Exclusion Criteria
- History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery
- History of intussusception
- Impairment of immunological function, including Severe Combined Immunodeficiency (SCID)
- Acute disease, severe chronic disease, or chronic disease during the acute period
- Uncontrolled epilepsy, encephalopathy, seizure, or other progressive neurological disease
- Hypersensitivity to any component of the rotavirus vaccine, OPV, or DTaP
- Prior receipt of any rotavirus vaccine
- Fever, with an axillary temperature >=37.5 °C (or equivalent) within 24 hours before study vaccination (study vaccination can be deferred until complete resolution of febrile illness)
- Clinical evidence of active gastrointestinal illness
- Received intramuscular, oral, or intravenous corticosteroid treatment since birth (topical, ophthalmic, and inhaled steroids are permitted)
- Resides in a household with an immunocompromised person
- Receipt of a blood transfusion or blood products, including immunoglobulins
- Participation in another interventional study within 14 days before the first study vaccination or during the study
- Receipt of an investigational or non-registered product other than the study vaccine within 30 days before the first study vaccination or during the study
- For participants in immunogenicity arms: inability to obtain a blood specimen at randomization visit (note: the visit may be rescheduled so that a baseline specimen may be obtained); history of polio, diphtheria, tetanus, or pertussis disease; previous vaccination against diphtheria, tetanus, pertussis, or poliomyelitis
- Any condition which, in the opinion of the investigator, may interfere with the evaluation of the study objectives
Data sourced from ClinicalTrials.gov (NCT02062385) and the linked publication. 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.