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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

GlaxoSmithKline Biologicals

Participant type

Pediatric, Healthy volunteers

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Decision date (initial)

2025-06-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

GlaxoSmithKline Biologicals

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety, Prophylaxis

To evaluate non-inferiority of the immune response of 2 doses of investigational varicella (VNS) vaccine compared to 2 doses of Varicella vaccine (VV) in terms of seroresponse rate to VZV at Day 43 post Dose 2.
To evaluate non-inferiority of the immune response of 2 doses of VNS vaccine compared to 2 doses of VV in terms of Geometric Mean Concentration (GMC) for Varicella zoster virus (VZV) at Day 43 post-Dose 2.

Secondary objectives 2

1. To evaluate the immune response of a second dose of VNS vaccine following a first dose of VV In terms of seroresponse rate and GMC for VZV at Day 43 post-Dose 2.
2. To evaluate the safety and the reactogenicity following the administration of each dose of VNS vaccine and VV in different study groups when co-administered with measles, mumps, and rubella (MMR) vaccine, hepatitis A virus (HAV) vaccine, and (if applicable) PCV.

Conditions and MedDRA coding

Varicella

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, Federal Agency For Medicines And Health Products, European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-003317-PIP02-22

Plan to share IPD

Yes

IPD plan description

When the study is completed at all the study sites, the study results will be shared with the study doctor, and the study doctor will explain the study results to subject parents/LARs. Subject parents/LARs may ask the study doctor for the child’s individual results.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 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
2. Written or witnessed/thumb printed informed consent obtained from the participant’s parent(s)/LAR(s) prior to performance of any study-specific procedure.
3. Healthy participants as established by medical history and clinical examination before entering into the study.
4. 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.
5. Only for children in countries where PCV is recommended at 12 to 15 months of age as per national immunization schedule and provided as part of the study interventions: − Participant who previously received the primary series of PCV in the first year of life with last dose at least 60 days prior to study entry.

Exclusion criteria 19

1. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
2. Planned administration of a vaccine in the period starting 30 days before the first dose and ending 43 days after the second dose of study interventions administration* (Visit 3), with the exception of inactivated influenza vaccine which may be given at any time during the study and administered at a different location than the study interventions.
3. Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study. - Up to 90 days prior to the study intervention administration: • For corticosteroids, this will mean prednisone equivalent ≥0.5 mg/kg/day with maximum of 20 mg/day for pediatric participants. Inhaled and topical steroids are allowed. • Administration of immunoglobulins and/or any blood products or plasma derivatives. - Up to 180 days prior to study interventions administration: long-acting immunemodifying drugs including among others immunotherapy (e.g., tumor necrosis factor-inhibitors), monoclonal antibodies (except the ones not interfering with the immune response to the study vaccines e.g., nirsevimab), antitumoral medication.
4. Previous vaccination against measles, mumps, and rubella.
5. Previous vaccination against hepatitis A virus.
6. Previous vaccination against varicella virus.
7. Only for children in countries where PCV is recommended at 12 to 15 months of age as per national immunization schedule and provided as part of the study interventions, participant who previously received a booster dose of any PCV.
8. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device).
9. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
10. Hypersensitivity to latex.
11. Major congenital defects, as assessed by the investigator.
12. Recurrent history of uncontrolled neurological disorders or seizures.
13. History of varicella disease.
14. Active untreated tuberculosis.
15. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
16. Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study interventions during the period beginning 30 days before the first dose of study interventions (Day -29 to Day 1), or their planned use during the study period.
17. Child in care.
18. Any study personnel’s immediate dependents, family, or household members.
19. Participants with the following high-risk individuals in their household: i) Immunocompromised individuals. ii) Pregnant women without documented history of varicella. iii) Newborn infants of mothers without documented history of varicella. iv) Newborn infants born less than (<) 28 weeks of gestation.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) antiglycoprotein E (gE) IgG for 2 doses of VNS vaccine compared to 2 doses of VV. 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 Time frame: At Day 133 (43 days post-dose 2)

Secondary endpoints 16

1. Percentage of participants with seroresponse to anti-VZV gE IgG for VV-VNS group. Time frame: At Day 133 (43 days post-dose 2)
2. GMC of anti-VZV gE IgG for VV-VNS group. Time frame: At Day 133 (43 days post-dose 2)
3. Percentage of participants reporting each solicited administration site event. Time frame: Day 1 (post-dose 1) to Day 4
4. Percentage of participants reporting each solicited administration site event. Time frame: Day 91 (Day 1 post-dose 2) to Day 94
5. Percentage of participants reporting each solicited systemic event. Time frame: Day 1 (post-dose 1) to Day 15
6. Percentage of participants reporting each solicited systemic event. Time frame: Day 91 (Day 1 post-dose 2) to Day 105
7. Percentage of participants reporting each solicited systemic event in terms of fever. Time frame: Day 1 (post-dose 1) to Day 22
8. Percentage of participants reporting each solicited systemic event in terms of fever. Time frame: Day 91 (Day 1 post-dose 2) to Day 112
9. Percentage of participants reporting each solicited administration site event. Time frame: Day 1 (post-dose 1) to Day 43
10. Percentage of participants reporting each solicited administration site event. Time frame: Day 91 (Day 1 post-dose 2) to Day 133
11. Percentage of participants reporting each solicited systemic event. Time frame: Day 1 (post-dose 1) to Day 43
12. Percentage of participants reporting each solicited systemic event. Time frame: Day 91 (Day 1 post-dose 2) to Day 133
13. Percentage of participants reporting unsolicited adverse events (AEs). Time frame: Day 1 (post-dose 1) to Day 43
14. Percentage of participants reporting unsolicited adverse events (AEs). Time frame: Day 91 (Day 1 post-dose 2) to Day 133
15. Percentage of participants reporting medically attended AEs (MAAE). Time frame: Day 1 (post-dose 1) to Day 271 (study end)
16. Percentage of participants reporting serious adverse events (SAEs). Time frame: Day 1 (post-dose 1) to Day 271 (study end)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

GlaxoSmithKline Biologicals

Sponsor organisation

GlaxoSmithKline Biologicals

Address

Rue De L'Institut 89

City

Rixensart

Postcode

1330

Country

Belgium

Scientific contact point

Organisation

GlaxoSmithKline Biologicals

Contact name

EU GSK Clinical Trials Call Center

Public contact point

Organisation

GlaxoSmithKline Biologicals

Contact name

EU GSK Clinical Trials Call Center

Third parties 13

Locations

2 EU/EEA countries · 7 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 23 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications