Health Trials

A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine and a Marketed Measles, Mumps and Rubella Vaccine When Administered as Intramuscular Injection to Healthy Children 12 to 15 Months of Age

ConditionChickenpox
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-15
SponsorGlaxoSmithKline

About this trial

This study aims to assess the immune response and safety of GSK's candidate chickenpox and marketed MMR vaccines when given to children 12 to 15 months of age via a muscle injection. It compares the GSK vaccines to Merck's chickenpox vaccine, administered just under the skin. Additionally, the study will evaluate the immune response and safety of giving the GSK vaccines along with other childhood vaccines through a muscle injection.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participant's parent(s)/ Legally acceptable representatives (LAR[s]), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiaries, return for follow-up visits).

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

Healthy participants as established by medical history and clinical examination before entering into the study.

A male or female between, and including, 12 to 15 months of age (i.e., from the day of 1-year birthday until the day before 16 months of age) at the time of the administration of study interventions.

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 (no laboratory testing required).

Hypersensitivity to latex.

Major congenital defects, as assessed by the investigator.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Candidate varicella vaccine

    Biological/Vaccine

    Investigational varicella vaccine administered intramuscularly.

  • Marketed varicella vaccine

    Biological/Vaccine

    Marketed varicella vaccine administered subcutaneously.

  • MMR vaccine

    Biological/Vaccine

    MMR vaccine administered subcutaneously or intramuscularly.

  • Hepatitis A vaccine

    Biological/Vaccine

    Hepatitis A vaccine co-administered intramuscularly.

  • PCV (pneumococcal conjugate vaccine) 13

    Biological/Vaccine

    The 13-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.

  • PCV 20

    Biological/Vaccine

    The 20-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.

  • Vaxneuvance

    Biological/Vaccine

    The Vaxneuvance (15-valent pneumococcal conjugate vaccine) co-administered intramuscularly. In some countries Vaxneuvancewill only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.

Treatment groups

911 Participants
are divided into 2 treatment groups
Group A: VNS+ MMR VaccineExperimental treatment 6 interventions
Group B: VV+MMR VaccineActive comparator 6 interventions

Trial outcomes

Primary outcomes

1

Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti- glycoprotein E (gE) Immunoglobulin (IgG)

The seroresponse rate is defined as the percentage of participants for whom the post-vaccination Day 43 anti VZV gE IgG concentration is above the seroresponse threshold.

Time frame
At Day 43
2

Geometric Mean Concentration (GMC) of anti-VZV gE IgG

Concentrations of anti-VZV gE IgG are presented as GMC and expressed in milli-international units per milliliter (mIU/mL) for each group.

Time frame
At Day 43
3

Percentage of participants with seroresponse to MMR antigens

The seroresponse rate is defined as the percentage of participants for whom the post-vaccination Day 43 anti-measles, mumps, and rubella antibody concentrations are above the seroresponse threshold.

Time frame
At Day 43
4

GMC of Anti-measles antibodies

Time frame
At Day 43

Secondary outcomes

1

Percentage of participants with seroresponse to demonstrate an acceptable immune response for IM administration of MMR vaccine

Time frame
At Day 43
2

Percentage of participants with seroresponse to MMR antigens with a reduced non-inferiority margin

Time frame
At Day 43
3

Percentage of participants reporting each solicited administration site events post-dose of investigational VNS vaccine or VV administration

Solicited administration site events include injection site redness, pain, and swelling.

Time frame
Day 1 (post-dose) to Day 4
4

Percentage of participants reporting each solicited administration site events post-dose of MMR vaccine administration

Solicited administration site events include injection site redness, pain and swelling.

Time frame
Day 1 (post-dose) to Day 4

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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