NCT00432523

Brief Summary

Primary objective: To compare if, when given concomitantly with VARIVAX® by the same route at 12-18 months of age using separate injection sites, a single dose of M-M-RTMII administered by IM route is as immunogenic as a single dose of M-M-RTMII administered by SC route in terms of response rates to measles, mumps and rubella at 42 days following the vaccination. AND/OR To compare if, when given concomitantly with M-M-RTMII by the same route at 12-18 months of age using separate injection sites, a single dose of VARIVAX® administered by IM route is as immunogenic as a single dose of VARIVAX® administered by SC route in terms of response rate to varicella at 42 days following the vaccination Secondary objectives:

  • To summarise the antibody titres to measles, mumps, rubella and varicella at 42 days following the vaccination in children immunised with M-M-R™II and VARIVAX® administered concomitantly at two separate injection sites by the same route IM or SC,
  • To evaluate the safety profiles of M-M-R™II and VARIVAX® administered concomitantly at two separate injection sites by the same route IM or SC.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
752

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_3

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2007

Completed
Last Updated

October 18, 2021

Status Verified

October 1, 2021

Enrollment Period

8 months

First QC Date

February 7, 2007

Last Update Submit

October 11, 2021

Conditions

MeaslesMumpsVaricella

Keywords

Prevention of : Measles, Mumps, Rubella and Varicella diseases

Interventions

M-M-R™II manufactured with recombinant Human Albumin (rHA) and VARIVAX®BIOLOGICAL

Eligibility Criteria

Age12 Months - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy subject of either gender,
  • Age 12 to 18 months ,
  • Consent form signed by both parent(s) or by the legal representative properly informed about the study,
  • Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.

You may not qualify if:

  • Prior receipt of measles, mumps, rubella or varicella vaccine either alone or in combination vaccine,
  • Known or suspected clinical history of infection with measles, mumps, rubella, varicella or zoster,
  • Any recent (≤30 days) exposure to measles, mumps or rubella,
  • Any recent (≤30 days) exposure to varicella or zoster involving:
  • Any recent (≤3 days) history of febrile illness
  • Any severe chronic disease,
  • Active untreated tuberculosis,
  • Known personal history of seizures,
  • Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems,
  • Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
  • Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed
  • Any recent tuberculin test (≤7 days) or scheduled tuberculin test through visit 2,
  • Any previous (≤150 days) receipt of immune serum globulin or any blood-derived products or scheduled to be administered through visit 2,
  • Any recent receipt of an inactivated or a live vaccine (≤30 days) or scheduled vaccination through visit 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

France, France

Location

Unknown Facility

Germany, Germany

Location

Related Publications (1)

  • Gillet Y, Habermehl P, Thomas S, Eymin C, Fiquet A. Immunogenicity and safety of concomitant administration of a measles, mumps and rubella vaccine (M-M-RvaxPro) and a varicella vaccine (VARIVAX) by intramuscular or subcutaneous routes at separate injection sites: a randomised clinical trial. BMC Med. 2009 Apr 14;7:16. doi: 10.1186/1741-7015-7-16.

    PMID: 19366435DERIVED

MeSH Terms

Conditions

MeaslesMumpsChickenpoxRubella

Interventions

Chickenpox Vaccine

Condition Hierarchy (Ancestors)

Morbillivirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsRubulavirus InfectionsParotitisParotid DiseasesSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesVaricella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsRubivirus InfectionsTogaviridae Infections

Intervention Hierarchy (Ancestors)

Herpesvirus VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Anne FIQUET, MD

    SPMSD

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2007

First Posted

February 8, 2007

Study Start

January 20, 2005

Primary Completion

September 5, 2005

Study Completion

September 5, 2005

Last Updated

October 18, 2021

Record last verified: 2021-10

Locations

FR(1)DE(1)