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A Study on the Immune Response and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine, When Administered as Intramuscular Injection to Healthy Children 15 Months to 6 Years of Age

ConditionsMeaslesMeasles-Mumps-Rubella+Chickenpox Vaccine
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age15-6
SponsorGlaxoSmithKline

About this trial

This study is evaluating the immunogenicity and safety of intramuscular administration of the investigational MMRVNS vaccine compared to intramuscular administration of the MMRV (Merck's measles, mumps, rubella and varicella) vaccine (ProQuad) that is already licensed for this route, when administered as a second dose in children 15 months to 6 years of age who were previously primed with a first dose of any combination of measles, mumps, rubella and varicella-containing vaccine(s).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants' parent(s)/legally acceptable representative(s) (LAR(s)) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.

Written or witnessed/thumb printed informed consent obtained from the participants parent(s)/LAR(s) prior to performance of any study specific procedure.

Informed assent obtained from the participants in line with local rules and regulations.

Healthy participants as established by medical history and clinical examination at screening.

Disqualifiers

History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, including hypersensitivity to neomycin or, gelatin.

Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

Hypersensitivity to latex.

Unstable chronic conditions as determined by medical history and physical examination.

Trial design

Design model

Parallel

Treatments tested in this trial

  • MMRVNS

    Biological/Vaccine

    One dose of MMRVNS administered intramuscularly.

  • MMRV

    Biological/Vaccine

    One dose of MMRV administered intramuscularly.

Treatment groups

1,209 Participants
are divided into 2 treatment groups
Group A: MMRVNS GroupExperimental treatment 1 intervention
Group B: MMRV GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Seroresponse of Immunoglobulin G (IgG) concentrations against measles

Time frame
At Day 43
2

Seroresponse of IgG concentrations against mumps

Time frame
At Day 43
3

Seroresponse of IgG concentrations against rubella

Time frame
At Day 43
4

Seroresponse of IgG concentrations against Varicella zoster virus (VZV)

Time frame
At Day 43

Secondary outcomes

1

Number of participants with any solicited administration site events

Solicited administration site events are injection site redness, pain/tenderness, swelling, and injection site varicella-like rash.

Time frame
From Day 1 to Day 4 for injection site redness, pain/tenderness and swelling; and from Day 1 to Day 43 for injection site varicella-like rash
2

Number of participants with any solicited systemic events

Solicited systemic events are somnolence (sleepiness/drowsiness), loss of appetite, fever, non-injection site varicella-like rash, measles/rubella-like rash and other rash.

Time frame
From Day 1 to Day 15 for somnolence and loss of appetite; Day 1 to Day 22 for fever; and Day 1 to Day 43 for varicella-like rash, measles/rubella-like rash and other rash
3

Number of participants with any unsolicited adverse events (AEs)

Time frame
From Day 1 up to Day 43 (during the 43 days following study intervention administration)
4

Number of participants with any medically attended adverse events (MAAEs)

Time frame
From Day 1 up to Day 181 (during the 181 days following study intervention administration)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GlaxoSmithKline

Lead sponsor

Source ClinicalTrials.gov
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