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MMR at 6 Months Trial

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT03780179
Collaborator
(none)
6,540
Enrollment
2
Locations
2
Arms
32.8
Actual Duration (Months)
3270
Patients Per Site
99.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Biological: MMRvaxpro
  • Biological: Placebo
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
6540 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomization to intervention: MMRvaxpro at 6 months of age, or placebo-vaccine (solvent only)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 :
Apr 15, 2019
Actual Primary Completion Date :
Jan 7, 2022
Actual Study Completion Date :
Jan 7, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: MMRvaxpro

Biological: MMRvaxpro
MMRvaxpro vaccine
Placebo Comparator: Placebo

Biological: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. Humoral immunogenicity [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Months to 7 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rigshospitalet Copenhagen Copenhagen Ø Denmark 2100
2 Herlev Hospital Herlev Denmark 2730

Sponsors and Collaborators

  • Rigshospitalet, Denmark

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lone Graff Stensballe, Pediatrician, associate professor, PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT03780179
Other Study ID Numbers:
  • LGS.MMR.01.2016.2022
First Posted:
Dec 19, 2018
Last Update Posted:
Jan 13, 2022
Last Verified:
Jan 1, 2022
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, Pediatrician, associate professor, PhD, Rigshospitalet, Denmark
measles-mumps-rubella vaccine
Additional relevant MeSH terms:
Rubella

Study Results

No Results Posted as of Jan 13, 2022