Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024)

NCT ID: NCT02062385

Last Updated: 2018-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 4040 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-30
• Study Completion Date: 2015-06-11

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.

Conditions

Rotavirus Gastroenteritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

V260 with staggered EPI

V260 administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered China Expanded Program on Immunizations (EPI) as follows: Oral poliovirus vaccine (OPV) administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and diphtheria, tetanus, acellular pertussis vaccine (DTaP) administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months

Group Type: EXPERIMENTAL

V260

Intervention Type: BIOLOGICAL

V260 (RotaTeq™; live, oral, pentavalent rotavirus vaccine)

OPV

Intervention Type: BIOLOGICAL

Oral poliovirus vaccine administered according to the standard of care

DTaP

Intervention Type: BIOLOGICAL

Diphtheria, Tetanus, Acellular Pertussis vaccine administered according to the standard of care

Placebo with staggered EPI

Placebo administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months

Group Type: PLACEBO_COMPARATOR

Placebo to V260

Intervention Type: BIOLOGICAL

Placebo control

OPV

Intervention Type: BIOLOGICAL

Oral poliovirus vaccine administered according to the standard of care

DTaP

Intervention Type: BIOLOGICAL

Diphtheria, Tetanus, Acellular Pertussis vaccine administered according to the standard of care

V260 with concomitant EPI

V260 administered as a 2 mL oral solution at age \~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months

Group Type: EXPERIMENTAL

V260

Intervention Type: BIOLOGICAL

V260 (RotaTeq™; live, oral, pentavalent rotavirus vaccine)

OPV

Intervention Type: BIOLOGICAL

Oral poliovirus vaccine administered according to the standard of care

DTaP

Intervention Type: BIOLOGICAL

Diphtheria, Tetanus, Acellular Pertussis vaccine administered according to the standard of care

Placebo with concomitant EPI

Placebo administered as a 2 mL oral solution at age \~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months

Group Type: PLACEBO_COMPARATOR

Placebo to V260

Intervention Type: BIOLOGICAL

Placebo control

OPV

Intervention Type: BIOLOGICAL

Oral poliovirus vaccine administered according to the standard of care

DTaP

Intervention Type: BIOLOGICAL

Diphtheria, Tetanus, Acellular Pertussis vaccine administered according to the standard of care

Interventions

V260

V260 (RotaTeq™; live, oral, pentavalent rotavirus vaccine)

Intervention Type: BIOLOGICAL

Placebo to V260

Placebo control

Intervention Type: BIOLOGICAL

OPV

Oral poliovirus vaccine administered according to the standard of care

Intervention Type: BIOLOGICAL

DTaP

Diphtheria, Tetanus, Acellular Pertussis vaccine administered according to the standard of care

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 12 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: RESULT

PMID: 28935470 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30808567 (View on PubMed)

Other Identifiers

V260-024

Identifier Type: -

Identifier Source: org_study_id