## Protocol Section
### Identification Module
**NCT ID:** NCT03780179

**Brief Title:** MMR at 6 Months Trial

**Official Title:** Measles-mumps-rubella Vaccine at 6 Months of Age, Immunology, and Childhood Morbidity in a High-income Setting

#### Organization Study ID Info
**ID:** LGS.MMR.01.2016.2022
#### Organization
**Class:** OTHER
**Full Name:** Rigshospitalet, Denmark
### Status Module
#### Completion Date
**Date:** 2022-01-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-01-13

**Type:** ACTUAL

**Last Update Submit Date:** 2022-01-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-01-07

**Type:** ACTUAL

#### Start Date
**Date:** 2019-04-15

**Type:** ACTUAL

**Status Verified Date:** 2022-01

#### Study First Post Date
**Date:** 2018-12-19
**Type:** ACTUAL
**Study First Submit Date:** 2018-12-17
**Study First Submit QC Date:** 2018-12-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Rigshospitalet, Denmark

#### Responsible Party

**Investigator Affiliation:** Rigshospitalet, Denmark

**Investigator Full Name:** Lone Graff Stensballe

**Investigator Title:** Pediatrician, associate professor, PhD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Meales-mumps-rubella Vaccine

**Keywords:**

- measles-mumps-rubella vaccine

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

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

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 6540

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Biological: MMRvaxpro

**Label:** MMRvaxpro

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Biological: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- MMRvaxpro

**Description:** MMRvaxpro vaccine

**Name:** MMRvaxpro

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Placebo

**Name:** Placebo

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Humoral immunogenicity

**Time Frame:** 1 months after intervention

**Description:** 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.

**Measure:** Hospitalisation for infection

**Time Frame:** 6-12 months of age

### Eligibility Module

**Eligibility 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.

**Maximum Age:** 7 Months

**Minimum Age:** 5 Months

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Copenhagen

**Country:** Denmark

**Facility:** Rigshospitalet

**State:** Copenhagen Ø

**Zip:** 2100

**Location 2:**

**City:** Herlev

**Country:** Denmark

**Facility:** Herlev Hospital

**Zip:** 2730

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000018355

- Term: Rubivirus Infections

- ID: D000014036

- Term: Togaviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000007239

- Term: Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11440

- Name: Measles

- Relevance: LOW

- As Found: Unknown

- ID: M15229

- Name: Rubella

- Relevance: HIGH

- As Found: Rubella

- ID: M12064

- Name: Mumps

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16792

- Name: Togaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: T3653

- Name: Measles

- Relevance: LOW

- As Found: Unknown

- ID: T5072

- Name: Rubella

- Relevance: HIGH

- As Found: Rubella

### Condition Browse Module - Meshes

- ID: D000012409

- Term: Rubella

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
