ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 46 of 141 for:    "Measles"

Immunogenicity and Safety of Japanese Encephalitis Vaccine When Given With Measles-Mumps-Rubella Vaccine (JEV06)

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: NCT02880865
Recruitment Status : Completed
First Posted : August 26, 2016
Last Update Posted : August 22, 2018
Sponsor:
Collaborators:
Research Institute for Tropical Medicine,
INC Research
DF/Net Research, Inc.
Information provided by (Responsible Party):
PATH

Brief Summary:
This study aims to provide evidence that co-administration of measles-mumps-rubella vaccine (MMR) and live attenuated SA 14-14-2 Japanese encephalitis vaccine (CD-JEV) does not adversely affect immunogenicity or safety.

Condition or disease Intervention/treatment Phase
Encephalitis, Japanese Measles Mumps Rubella Biological: CD-JEV Biological: MMR Phase 4

Detailed Description:
When incorporating a new vaccine in the Expanded Programme on Immunization (EPI), it is important to provide evidence that it can be introduced concurrently with other routine pediatric vaccines without significantly impairing the immune response to any vaccine while maximizing coverage and minimizing cost. This non-inferiority study aims to compare CD-JEV and MMR responses in a population of children in a country where MMR introduction is ongoing or planned. This information will help the ministries of health evaluate the addition of CD-JEV into routine EPI.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 628 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Concurrent Administration of Live, Attenuated SA 14-14-2 Japanese Encephalitis Vaccine and Measles-Mumps-Rubella Vaccine in Infants 9-12 Months of Age in the Philippines
Actual Study Start Date : October 13, 2016
Actual Primary Completion Date : May 19, 2017
Actual Study Completion Date : July 11, 2017


Arm Intervention/treatment
Experimental: Group 1 - MMR and CD-JEV
Participants receiving one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0; Group 1 will also receive a second dose of MMR per the routine immunization schedule at D84 (12 months of age).
Biological: CD-JEV
Single 0.5 mL dose of World Health Organization prequalified live, attenuated SA 14-14-2 JE vaccine manufactured by Chengdu Institute of Biological Products, Chengdu, China, administered by subcutaneous injection
Other Names:
  • live attenuated SA 14-14-2 Japanese Encephalitis vaccine
  • CD.JEVAX
  • RS.JEV

Biological: MMR
Single 0.5 mL dose of live, attenuated measles-mumps-rubella vaccine (Schwarz measles virus, RIT 4385 mumps strain, and Wistar RA 27/3 rubella virus) manufactured by GlaxoSmithKline, Inc., administered by subcutaneous injection.
Other Names:
  • measles, mumps, rubella vaccine
  • Priorix

Experimental: Group 2 - MMR then CD-JEV
Participants receiving one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Group 2 will receive a second dose of MMR per the routine immunization schedule at D84 (12 months of age).
Biological: CD-JEV
Single 0.5 mL dose of World Health Organization prequalified live, attenuated SA 14-14-2 JE vaccine manufactured by Chengdu Institute of Biological Products, Chengdu, China, administered by subcutaneous injection
Other Names:
  • live attenuated SA 14-14-2 Japanese Encephalitis vaccine
  • CD.JEVAX
  • RS.JEV

Biological: MMR
Single 0.5 mL dose of live, attenuated measles-mumps-rubella vaccine (Schwarz measles virus, RIT 4385 mumps strain, and Wistar RA 27/3 rubella virus) manufactured by GlaxoSmithKline, Inc., administered by subcutaneous injection.
Other Names:
  • measles, mumps, rubella vaccine
  • Priorix




Primary Outcome Measures :
  1. Measles seropositivity rate [ Time Frame: 56 days after MMR vaccination ]
  2. Rubella seropositivity rate [ Time Frame: 56 days after MMR vaccination ]

Secondary Outcome Measures :
  1. Mumps seropositivity rate [ Time Frame: 56 days after MMR vaccination ]
  2. Geometric mean neutralizing antibody concentration (GMC) [ Time Frame: 56 days after MMR vaccination ]
  3. Anti-mumps Immunoglobulin G (IgG) mean index standard ratio [ Time Frame: 56 days after MMR vaccination ]
  4. Anti-rubella IgG GMC [ Time Frame: 56 days after MMR vaccination ]
  5. Measles, mumps, and rubella seroconversion rates [ Time Frame: 56 days after MMR vaccination ]
  6. Japanese encephalitis seropositivity rate [ Time Frame: 28 days after CD-JEV vaccination ]
  7. Anti-Japanese encephalitis neutralizing antibody geometric mean titers [ Time Frame: 28 days after CD-JEV vaccination ]
  8. Frequency counts of immediate reactions observed following vaccination [ Time Frame: 30 minutes following each vaccination ]
  9. Frequency counts of solicited local and systemic adverse events following vaccination [ Time Frame: 14 days following each vaccination ]
  10. Frequency counts of unsolicited adverse events following vaccination [ Time Frame: 28 days following each vaccination ]
  11. Frequency counts of serious adverse events following vaccination [ Time Frame: 112 days following first vaccination or until study end (expected to be 8 months) ]


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.


Ages Eligible for Study:   9 Months to 9 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 9 months to <10 months at the time of enrollment.
  • Residence in the study area.
  • At least one parent or guardian willing to provide written informed consent.
  • Generally healthy and free of obvious health problems as established by medical history, physical examination, and clinical judgment.
  • A parent or guardian is willing to attend all planned study visits and allow home visits and phone contacts, as required by the protocol.

Exclusion Criteria:

  • Previous receipt of any measles-mumps-rubella containing vaccine.
  • Previous receipt of any Japanese encephalitis vaccine.
  • History of measles, mumps, rubella, or Japanese encephalitis infection.
  • Administration of any other vaccine within 28 days prior to administration of a study vaccine or planned vaccination of any vaccine other than catch-up doses of routine EPI vaccines or oral polio vaccine during the 28 days after study vaccination.
  • History of allergic disease or known hypersensitivity to any component of the study vaccines and/or following administration of vaccines included in the local program of immunization.
  • Use of any investigational or non-registered drug within 90 days prior to the administration of study vaccines or planned administration during the study period.
  • Administration of immunoglobulins and/or any blood products within 90 days prior to the administration of study vaccines or planned administration during the study period.
  • Chronic administration (defined as >7 days) of immunosuppressing or other immune-modifying agents within 14 days before or after vaccination (including systemic corticosteroids equivalent to prednisone ≥0.5 mg/kg/day; topical and inhaled steroids are allowed).
  • Primary or acquired immunodeficiency, including HIV infection, or a family history of congenital or hereditary immunodeficiency as reported by parent.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history or physical examination, which might interfere with the study objectives.
  • Severely malnourished infants as measured by World Health Organization weight-for-height tables (Z-score < -3).
  • Any condition or criterion that, in the opinion of the study physician, might compromise the well-being of the participant, compliance with study procedures, or interpretation of the outcomes of the study.
  • Acute illness at the time of enrollment defined as the presence of a moderate or severe illness with fever (axillary temperature ≥38.0°C) or without fever (severity determined at the discretion of the study physician). Acute illness is a temporary exclusion. Vaccination should be postponed at least 7 days after recovery. A visit for reassessment may be scheduled 7 days or more after temporary exclusion illness is resolved. Eligibility for study participation must be reassessed again at the next visit.

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): NCT02880865


Locations
Philippines
Research Institute for Tropical Medicine
Manila, Philippines
Sponsors and Collaborators
PATH
Research Institute for Tropical Medicine,
INC Research
DF/Net Research, Inc.
Investigators
Principal Investigator: Maria Rosario Capeding, MD Research Institute for Tropical Medicine,

Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT02880865     History of Changes
Other Study ID Numbers: JEV06 (862058-1)
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The study team agrees that the practice of offering study results to participants in human research is fundamental to the ethical principle of respect for persons. However, the sponsor prefers to report at the aggregate level to maintain participant confidentiality and ensure results are community-based. Thus, the sponsor plans to report results at the aggregate level. The sponsor will produce a poster of the results to be placed at each health center. A community meeting may also be held to communicate the results. Aggregate results will also be posted on clinicaltrials.gov.

Keywords provided by PATH:
vaccine

Additional relevant MeSH terms:
Measles
Encephalitis
Rubella
Encephalitis, Japanese
Mumps
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Rubivirus Infections
Togaviridae Infections
Encephalitis, Arbovirus
Arbovirus Infections
Encephalitis, Viral
Central Nervous System Viral Diseases
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections
Rubulavirus Infections
Parotitis
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Vaccines