MMR at 6 Months Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

6540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-15

Study Completion Date

2022-01-07

Brief Summary

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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

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Detailed Description

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Conditions

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Meales-mumps-rubella Vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MMRvaxpro

Group Type EXPERIMENTAL

MMRvaxpro

Intervention Type BIOLOGICAL

MMRvaxpro vaccine

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo

Interventions

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MMRvaxpro

MMRvaxpro vaccine

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

5 Months

Maximum Eligible Age

7 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No