A Study on the 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 how well-tolerated GSK's investigational varicella vaccine (VNS Vaccine) is, in comparison to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted on healthy children aged 12 to 15 months, and 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 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 (no laboratory testing required).

Hypersensitivity to latex.

Recurrent history of uncontrolled neurological disorders or seizures.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Investigational varicella vaccine

    Biological/Vaccine

    1 dose of investigational varicella vaccine administered subcutaneously.

  • Marketed varicella vaccine

    Biological/Vaccine

    1 dose of marketed varicella vaccine administered subcutaneously.

  • Measles, mumps, and rubella vaccine

    Biological/Vaccine

    1 dose of measles, mumps, and rubella vaccine co-administered subcutaneously or intramuscularly.

  • Hepatitis A vaccine

    Biological/Vaccine

    1 dose of hepatitis A vaccine co-administered intramuscularly.

  • PCV (pneumococcal conjugate vaccine) 13

    Biological/Vaccine

    1 dose of 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

    1 dose of 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

    1 dose of 15-valent pneumococcal conjugate (Vaxneuvance) 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

750 Participants
are divided into 2 treatment groups
Group A: VNS GroupExperimental treatment 6 interventions
Group B: VV GroupActive comparator 6 interventions

Trial outcomes

Primary outcomes

1

Percentage of participants reporting each solicited administration site events

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

Time frame
Day 1 (post-dose) to Day 4
2

Percentage of participants reporting each solicited systemic event

Solicited systemic events include drowsiness, loss of appetite and irritability.

Time frame
Day 1 (post-dose) to Day 15
3

Percentage of participants reporting each solicited systemic event in terms of fever

Fever is defined as temperature greater than or equal to (\>=) 38.0°C (100.4°F) by any route (the preferred location for measuring temperature is the axilla).

Time frame
Day 1 (post-dose) to Day 22
4

Percentage of participants reporting each solicited administration site events

Solicited administration site include injection site varicella-like rash.

Time frame
Day 1 (post-dose) to Day 43

Secondary outcomes

Other outcomes

Sponsors and contacts

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