Phase 3
N=4,040
Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024)
Rotavirus Gastroenteritis
Bottom Line
View on ClinicalTrials.gov: NCT02062385 ↗Enrolled (actual)
4,040
Serious AEs
16.8%
Results posted
Apr 2016
Primary outcome: Primary: Number of Participants With Any Severity of Rotavirus Gastroenteritis — 34; 109 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- V260 (Biological); Placebo to V260 (Biological); OPV (Biological); DTaP (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jun 2015
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 | — |
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.
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). 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.