MMR at 6 Months Trial

NCT03780179 | Completed Phase 4

• 1 other identifier: LGS.MMR.01.2016.2022
• Study Type: interventional
• Target: 6,540
• Locations: 1 country
• Sites: 2

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

Conditions

Meales-mumps-rubella Vaccine

Keywords

measles-mumps-rubella vaccine

Outcome Measures

Primary Outcomes (2)

• Humoral immunogenicity

  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.

  1 months after intervention

• Hospitalisation for infection

  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.

  6-12 months of age

Study Arms (2)

MMRvaxpro

EXPERIMENTAL

Biological: MMRvaxpro

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

MMRvaxpro BIOLOGICAL

MMRvaxpro vaccine

MMRvaxpro

Placebo BIOLOGICAL

Placebo

Placebo

Eligibility Criteria

• Age: 5 Months - 7 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (2)

Rigshospitalet

Copenhagen, Copenhagen Ø, 2100, Denmark

Location

Herlev Hospital

Herlev, 2730, Denmark

Location

Related Publications (4)

• Buus S, Vittrup DM, Schmidt JD, Jensen A, Stryhn A, Stensballe LG. Measles-mumps-rubella-vaccination at 6 months of age induces measles-specific T cell responses: a randomized controlled trial. Front Immunol. 2025 Mar 17;16:1546253. doi: 10.3389/fimmu.2025.1546253. eCollection 2025.

  PMID: 40165977 DERIVED

• Sorensen JK, Jensen A, Zimakoff AC, Vittrup DM, Malon M, Kim S, Hatley EV, Bybjerg-Grauholm J, Kaur S, Pociot F, Stensballe LG, Svensson J. Genetic associations with measles PRNT and IgG antibody response to MMR vaccination in 6- and 15-month-old children. Vaccine. 2025 Mar 19;50:126788. doi: 10.1016/j.vaccine.2025.126788. Epub 2025 Feb 5.

  PMID: 39914254 DERIVED

• Vittrup DM, Jensen A, Sorensen JK, Zimakoff AC, Malon M, Charabi S, Johansen MR, Simoes EAF, Kirkby NS, Buus S, Svensson J, Stensballe LG. Immunogenicity and reactogenicity following MMR vaccination in 5-7-month-old infants: a double-blind placebo-controlled randomized clinical trial in 6540 Danish infants. EClinicalMedicine. 2024 Jan 12;68:102421. doi: 10.1016/j.eclinm.2023.102421. eCollection 2024 Feb.

  PMID: 38292039 DERIVED

• Zimakoff AC, Jensen A, Vittrup DM, Herlufsen EH, Sorensen JK, Malon M, Svensson J, Stensballe LG. Measles, mumps, and rubella vaccine at age 6 months and hospitalisation for infection before age 12 months: randomised controlled trial. BMJ. 2023 Jun 7;381:e072724. doi: 10.1136/bmj-2022-072724.

  PMID: 37286215 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatrician, associate professor, PhD

Model Details: Randomization to intervention: MMRvaxpro at 6 months of age, or placebo-vaccine (solvent only)

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 19, 2018
• Study Start: April 15, 2019
• Primary Completion: January 7, 2022
• Study Completion: January 7, 2022
• Last Updated: January 13, 2022

Record last verified: 2022-01

Locations

DK (2)