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

NCT02062385 | Completed Phase 3 Results DMC

• 1 other identifier: V260-024
• Study Type: interventional
• Target: 4,040
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Any Severity of Rotavirus Gastroenteritis

  The number of participants with rotavirus gastroenteritis (RVGE) caused by naturally-occurring wild-type rotavirus (regardless of serotype or disease severity) was assessed. The case definition of RVGE included 1) 3 or more watery or looser-than-normal stools within a 24-hour period and/or forceful vomiting, and 2) naturally-occurring wild-type rotavirus must be detected in a stool specimen taken within 7 days after the onset of symptoms.

  From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months)

Secondary Outcomes (7)

• Percentage of Participants With Elevated Temperature

  Up to 30 days after any dose of V260 or Placebo

• Percentage of Participants With Vomiting or Diarrhea

  Up to 30 days after any dose of V260 or Placebo

• Percentage of Participants With Intussusception

  Up to 15 months

• Number of Participants With Severe Rotavirus Gastroenteritis

  From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months)

• Percentage of Participants Who Achieved Seroprotection Against Poliovirus Type 1, 2, or 3

  Baseline and between 28 and 56 days after the third OPV vaccination

Study Arms (4)

V260 with staggered EPI

EXPERIMENTAL

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

Biological: V260; Biological: OPV; Biological: DTaP

Placebo with staggered EPI

PLACEBO COMPARATOR

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

Biological: Placebo to V260; Biological: OPV; Biological: DTaP

V260 with concomitant EPI

EXPERIMENTAL

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

Biological: V260; Biological: OPV; Biological: DTaP

Placebo with concomitant EPI

PLACEBO COMPARATOR

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

Biological: Placebo to V260; Biological: OPV; Biological: DTaP

Interventions

V260 BIOLOGICAL

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

V260 with concomitant EPI; V260 with staggered EPI

Placebo to V260 BIOLOGICAL

Placebo control

Placebo with concomitant EPI; Placebo with staggered EPI

OPV BIOLOGICAL

Oral poliovirus vaccine administered according to the standard of care

Placebo with concomitant EPI; Placebo with staggered EPI; V260 with concomitant EPI; V260 with staggered EPI

DTaP BIOLOGICAL

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

Placebo with concomitant EPI; Placebo with staggered EPI; V260 with concomitant EPI; V260 with staggered EPI

Eligibility Criteria

• Age: 6 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (2)

• 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.

  PMID: 28935470 RESULT

• 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.

  PMID: 30808567 DERIVED

MeSH Terms

Interventions

Rotavirus Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: February 13, 2014
• Study Start: May 30, 2014
• Primary Completion: June 11, 2015
• Study Completion: June 11, 2015
• Last Updated: November 27, 2018
• Results First Posted: April 4, 2016

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share