A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given 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

The purpose of this study is to assess the consistency of immune response to three different lots of GSK's investigational varicella vaccine (VNS Vaccine), and to compare the safety and immune response of VNS vaccine to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted in healthy children aged 12 to 15 months, who have neither contracted varicella nor received a varicella vaccination.

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.

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_Lot 1

    Biological/Vaccine

    Investigational varicella vaccine of Lot 1 administered subcutaneously.

  • Investigational varicella vaccine_Lot 2

    Biological/Vaccine

    Investigational varicella vaccine of Lot 2 administered subcutaneously.

  • Investigational varicella vaccine_Lot 3

    Biological/Vaccine

    Investigational varicella vaccine of Lot 3 administered subcutaneously.

  • Marketed varicella vaccine_Lot 1

    Biological/Vaccine

    Marketed varicella vaccine of Lot 1 administered subcutaneously.

  • Marketed varicella vaccine_Lot 2

    Biological/Vaccine

    Marketed varicella vaccine of Lot 2 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

1,840 Participants
are divided into 5 treatment groups
Group A: VNS_Lot 1 GroupExperimental treatment 6 interventions
Group B: VNS_Lot 2 GroupExperimental treatment 6 interventions
Group C: VNS_Lot 3 GroupExperimental treatment 6 interventions
Group D: VV_Lot 1 GroupActive comparator 6 interventions
Group E: VV_Lot 2 GroupActive comparator 6 interventions

Trial outcomes

Primary outcomes

1

Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti-glycoprotein E (gE) Immunoglobulin (IgG) for the 3 lots of VNS vaccine groups

Seroresponse is defined as post-vaccination (Day 43) anti-VZV gE IgG antibody concentration greater than or equal to (\>=) 300 milli-international units per milliliter (mIU/mL) among participants who were seronegative \[(antibody concentration less than (\<) LLOQ (Lower limit of quantification)\] before vaccination. A seronegative participant is a participant whose antibody concentration is below the LLOQ of the assay. A seropositive participant is a participant whose antibody concentration is greater than or equal to the LLOQ of the assay.

Time frame
At Day 43
2

Geometric Mean Concentration (GMC) of anti-VZV gE IgG for the 3 lots of VNS vaccine groups

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

Time frame
At Day 43
3

Percentage of participants with seroresponse to anti-VZV gE IgG for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups

Seroresponse is defined as post-vaccination (Day 43) anti-VZV gE IgG concentration \>= 300 mIU/mL among participants who were seronegative (antibody concentration \< LLOQ) before vaccination. A seronegative participant is a participant whose antibody concentration is below the LLOQ of the assay. A seropositive participant is a participant whose antibody concentration is greater than or equal to the LLOQ of the assay.

Time frame
At Day 43
4

GMCs of anti-VZV gE IgG for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups

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

Time frame
At Day 43

Secondary outcomes

1

Anti-measles antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups

Time frame
At Day 43
2

Anti-mumps antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups

Time frame
At Day 43
3

Anti-rubella antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups

Time frame
At Day 43
4

Percentage of participants with seroresponse to anti-measles for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups

Seroresponse is defined as post-vaccination (Day 43) anti-measles antibody concentration \>= cut-off value among participants who were seronegative (antibody concentration \< cut-off value) before vaccination. The assay cut-off values for anti-measles will be defined by the laboratory before the analysis.

Time frame
At Day 43

Other outcomes

Sponsors and contacts

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