Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02062385
Recruitment Status : Completed
First Posted : February 13, 2014
Results First Posted : April 4, 2016
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Rotavirus Gastroenteritis Biological: V260 Biological: Placebo to V260 Biological: OPV Biological: DTaP Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4040 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants
Actual Study Start Date : May 30, 2014
Actual Primary Completion Date : June 11, 2015
Actual Study Completion Date : June 11, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gastroenteritis

Arm Intervention/treatment
Experimental: 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
Biological: V260
V260 (RotaTeq™; live, oral, pentavalent rotavirus vaccine)

Biological: OPV
Oral poliovirus vaccine administered according to the standard of care

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

Placebo Comparator: 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
Biological: Placebo to V260
Placebo control

Biological: OPV
Oral poliovirus vaccine administered according to the standard of care

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

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

Biological: OPV
Oral poliovirus vaccine administered according to the standard of care

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

Placebo Comparator: 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
Biological: Placebo to V260
Placebo control

Biological: OPV
Oral poliovirus vaccine administered according to the standard of care

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




Primary Outcome Measures :
  1. Number of Participants With Any Severity of Rotavirus Gastroenteritis [ Time Frame: From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months) ]
    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.


Secondary Outcome Measures :
  1. Percentage of Participants With Elevated Temperature [ Time Frame: Up to 30 days after any dose of V260 or Placebo ]
    Elevated temperature (temperature >=37.5°C axillary or equivalent) was noted by the guardian and recorded on the Vaccination Report Card during Day 1 to Day 14 after each dose of vaccination. Elevated temperature reported by the guardian was also collected as an adverse event (pyrexia) during Day 15 to Day 30 after each dose of vaccination. The percentage of participants with axillary temperature >=37.5 °C or an adverse event of pyrexia was assessed.

  2. Percentage of Participants With Vomiting or Diarrhea [ Time Frame: Up to 30 days after any dose of V260 or Placebo ]
    Episodes of vomiting and diarrhea were noted by the guardian and recorded on the Vaccination Record Card during Day 1 to Day 14 after each dose of vaccination. Vomiting and diarrhea reported by the guardian were also collected as an adverse event during Day 15 to Day 30 after any dose of vaccination. The percentage of participants with an episode or an adverse event of vomiting or diarrhea was assessed.

  3. Percentage of Participants With Intussusception [ Time Frame: Up to 15 months ]
    Episodes of intussusception were collected from the time of written consent until the end of study. The percentage of participants with an episode of intussusception was assessed.

  4. Number of Participants With Severe Rotavirus Gastroenteritis [ Time Frame: From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months) ]
    The number of participants with severe 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. Severe RVGE was defined as >=11 on the Vesikari Scoring System, a composite of the seven parameters related to symptoms and treatment with an overall range from 0 to 20.

  5. Percentage of Participants Who Achieved Seroprotection Against Poliovirus Type 1, 2, or 3 [ Time Frame: Baseline and between 28 and 56 days after the third OPV vaccination ]
    The percentage of participants who achieved seroprotection against poliovirus Type 1, 2, or 3 was assessed. Seroprotection was defined as a neutralizing antibody titer >=1:8. This outcome was evaluated only in participants receiving concomitant administration of V260 and OPV.

  6. Percentage of Participants With Any Adverse Event [ Time Frame: Up to 30 days after any dose of V260 or Placebo ]
    An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the sponsor's product, is also an adverse event.

  7. Percentage of Participants Seropositive to Diphtheria, Pertussis, or Tetanus Antigens [ Time Frame: Baseline and between 28 and 51 days after the third DTaP vaccination ]
    The percentage of participants seropositive to diphtheria, pertussis, or tetanus antigens was assessed. Seropositive was defined as the following: 1) anti-diphtheria antibody titers >=0.1 International Units (IU)/mL, 2) anti-tetanus antibody titers >=0.1 IU/mL, 3) antipertussis toxin antibody titers >=20 Enzyme-linked Immunosorbent Assay (ELISA) Units (EU)/mL, 4) anti-pertussis filamentous hemagglutinin (FHA) antibody titers >=20 EU/mL. This outcome was evaluated only in participants receiving concomitant administration of V260 and EPI.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Weeks to 12 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02062385


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Study Director: Medical Director Merck Sharp & Dohme Corp.
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02062385    
Other Study ID Numbers: V260-024
First Posted: February 13, 2014    Key Record Dates
Results First Posted: April 4, 2016
Last Update Posted: November 27, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases