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MMR at 6 Months Trial

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ClinicalTrials.gov Identifier: NCT03780179
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Lone Graff Stensballe, Rigshospitalet, Denmark

Brief Summary:
Randomised, double-blind clinical trial to test humoral and cellular immunogenicity, and potential in-direct beneficial effect of the MMRvaxpro-vaccine administered at 6 months of age

Condition or disease Intervention/treatment Phase
Meales-mumps-rubella Vaccine Biological: MMRvaxpro Biological: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization to intervention: MMRvaxpro at 6 months of age, or placebo-vaccine (solvent only)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Measles-mumps-rubella Vaccine at 6 Months of Age, Immunology, and Childhood Morbidity in a High-income Setting
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023


Arm Intervention/treatment
Experimental: MMRvaxpro Biological: MMRvaxpro
MMRvaxpro vaccine

Placebo Comparator: Placebo Biological: Placebo
Placebo




Primary Outcome Measures :
  1. Humoral immunogenicity [ Time Frame: 1 months after intervention ]
    The plaque reduction neutralisation test (PRNT), which measures the serum dilution capable of preventing 50% of plaque formation induced by measles virus in cell cultures, has been considered the most reliable criterion for the serologic evaluation of measles immunity. For PNRT, the protective cutoff titer is defined to be >120. A frequency of 95% seroconversion rate, i.e. children mounting a protective level of humoral immunity according to the abovementioned cutoff value after MMR-vaccination at 6 M of age will be considered sufficient to suggest implementation of MMR at 6 M in the Danish vaccination programme.

  2. Hospitalisation for infection [ Time Frame: 6-12 months of age ]
    Significant decrease in hospitalisation for infection measured as repeated events from 6 to 12 months of age in children randomised to MMR at 6 M compared to children randomised to placebo. Information about hospitalisation for infection will be obtained from the national Danish Patient Register, where all Danish inhabitants are followed-up during all hospital contacts.



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Ages Eligible for Study:   5 Months to 7 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gestational age of 32+ weeks.
  • Birth weight of 1000+ grams.
  • Signed informed consent from the parents.

Exclusion Criteria:

  • Immune-deficiency (primary or acquired) or -suppression.
  • Intake of immune modulating medicine (including high doses of corticosteroids) (M-M-RVAXPRO is not contraindicated in individuals who are receiving topical or low-dose parenteral corticosteroids, e.g. for asthma prophylaxis or replacement therapy).
  • Signs of severe illness or major malformation.
  • No Danish-speaking parent.
  • Children with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g., hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion are excluded.
  • Children with known fructose intolerance, thrombocytopenia or any coagulation disorder will be excluded.
  • Children who received blood or plasma transfusions, or administration of human immune serum globulin within the last 3 months will be excluded.
  • Further, children are excluded from the trial if any contraindication is suspected: history of hypersensitivity to any measles, mumps, or rubella vaccine, or to any of the excipients, including neomycin.
  • Children with active untreated tuberculosis, blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems will be excluded.

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): NCT03780179


Contacts
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Contact: Lone G Stensballe, MD, PhD +45 35459727 lone.graff.stensballe@regionh.dk

Locations
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Denmark
Rigshospitalet Recruiting
Copenhagen, Copenhagen Ø, Denmark, 2100
Contact: Lone G Stensballe, MD, PhD    3545 9727 ext 45    lone.graff.stensballe@regionh.dk   
Principal Investigator: Lone G Stensballe, MD, PhD         
Herlev Hospital Recruiting
Herlev, Denmark, 2730
Contact: Jannet Svensson, MD, PhD    +4538681089    Jannet.Svensson@regionh.dk   
Principal Investigator: Jannet SVensson, MD, PhD         
Sponsors and Collaborators
Rigshospitalet, Denmark

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Responsible Party: Lone Graff Stensballe, Pediatrician, associate professor, PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03780179     History of Changes
Other Study ID Numbers: LGS.MMR.01.2016.2022
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Lone Graff Stensballe, Rigshospitalet, Denmark:
measles-mumps-rubella vaccine
Additional relevant MeSH terms:
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Rubella
Rubivirus Infections
Togaviridae Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs