Clinical trial NCT02062385: Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024)
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rotavirus Gastroenteritis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2014-02-13
Enrollment: 4040
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Primary outcomes:
measure: Number of Participants With Any Severity of Rotavirus Gastroenteritis
timeFrame: From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months)
Secondary outcomes:
measure: Percentage of Participants With Elevated Temperature
timeFrame: Up to 30 days after any dose of V260 or Placebo
measure: Percentage of Participants With Vomiting or Diarrhea
timeFrame: Up to 30 days after any dose of V260 or Placebo
measure: Percentage of Participants With Intussusception
timeFrame: Up to 15 months
measure: Number of Participants With Severe Rotavirus Gastroenteritis
timeFrame: From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months)
measure: Percentage of Participants Who Achieved Seroprotection Against Poliovirus Type 1, 2, or 3
timeFrame: Baseline and between 28 and 56 days after the third OPV vaccination
measure: Percentage of Participants With Any Adverse Event
timeFrame: Up to 30 days after any dose of V260 or Placebo
measure: Percentage of Participants Seropositive to Diphtheria, Pertussis, or Tetanus Antigens
timeFrame: Baseline and between 28 and 51 days after the third DTaP vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Mo Z, Mo Y, Li M, Tao J, Yang X, Kong J, Wei D, Fu B, Liao X, Chu J, Qiu Y, Hille DA, Nelson M, Kaplan SS. Efficacy and safety of a pentavalent live human-bovine reassortant rotavirus vaccine (RV5) in healthy Chinese infants: A randomized, double-blind, placebo-controlled trial. Vaccine. 2017 Oct 13;35(43):5897-5904. doi: 10.1016/j.vaccine.2017.08.081. Epub 2017 Sep 19.
citation: Mo Z, Ma X, Luo P, Mo Y, Kaplan SS, Shou Q, Zheng M, Hille DA, Arnold BA; V260-024 Study Group; Liao X. Immunogenicity of pentavalent rotavirus vaccine in Chinese infants. Vaccine. 2019 Mar 22;37(13):1836-1843. doi: 10.1016/j.vaccine.2019.02.018. Epub 2019 Feb 23.