A Study on the Immune Response and Safety of the Second Dose of an Investigational Chickenpox Vaccine When Given to Healthy Children 3 Months After a First Dose at 12 to 15 Months of Age

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

About this trial

The purpose of this study is to evaluate the immune response and safety of GSKs investigational varicella vaccine (VNS Vaccine) compared to an already approved varicella vaccine, Varivax (VV), when administered as second dose to healthy children. 3 months after first dose at 12 to 15 months. The study will be conducted in children who have not previously contracted varicella or received a varicella vaccination.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participant's parent(s)/Legally acceptable representative (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 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 the first study interventions.

Disqualifiers

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

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

Hypersensitivity to latex.

Major congenital defects, as assessed by the investigator.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Investigational varicella vaccine

    Biological/Vaccine

    Investigational varicella vaccine administered subcutaneously.

  • Marketed varicella vaccine

    Biological/Vaccine

    Marketed varicella vaccine administered subcutaneously.

  • MMR vaccine

    Biological/Vaccine

    MMR vaccine co-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 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.

Treatment groups

600 Participants
are divided into 3 treatment groups
Group A: VV-VV GroupActive comparator 6 interventions
Group B: VNS-VNS GroupExperimental treatment 6 interventions
Group C: VV-VNS GroupExperimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti- glycoprotein E (gE) IgG for 2 doses of VNS vaccine compared to 2 doses of VV

Seroresponse is defined as post-vaccination (Day 43 post Dose 2) anti VZV gE Immunoglobulin (IgG) concentration greater than equal to (\>=) 300 milli-international units per milliliter (mIU/mL).

Time frame
At Day 133 (43 days post-dose 2)
2

Geometric Mean Concentration (GMC) of anti-VZV gE IgG for 2 doses of VNS vaccine compared to 2 doses of VV

Concentrations of anti-VZV gE IgG are presented as GMC and expressed in mIU/mL for each group.

Time frame
At Day 133 (within 43 days post-dose 2)

Secondary outcomes

1

Percentage of participants with seroresponse to anti-VZV gE IgG for VV-VNS group

Seroresponse is defined as post-vaccination (Day 43 post Dose 2) anti-VZV gE IgG concentration \>= 300 mIU/mL.

Time frame
At Day 133 (within 43 days post-dose 2)
2

GMC of anti-VZV gE IgG for VV-VNS group

Concentrations of anti-VZV gE IgG are presented as GMC and expressed in mIU/mL for each group.

Time frame
At Day 133 (within 43 days post-dose 2)
3

Percentage of participants reporting each solicited administration site event

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

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

Percentage of participants reporting each solicited administration site event

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

Time frame
Day 91 (post-dose 2) to Day 94

Other outcomes

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