A study on the immune response and safety of an investigational chickenpox vaccine when given to healthy children 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]

Trial duration

8 Jul 2025 → ongoing

Decision date (initial)

2025-05-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

GlaxoSmithKline Biologicals

External identifiers

EU CT number

2024-515869-33-00

ClinicalTrials.gov

NCT06740630

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety, Prophylaxis

To demonstrate the consistency of 3 manufacturing lots of VNS vaccine in terms of seroresponse rate to Varicella zoster virus (VZV) at Day 43.
• To demonstrate the consistency of 3 manufacturing lots of VNS vaccine in terms of Geometric Mean Concentration (GMC) for antibodies to VZV at Day 43.
• To demonstrate the non-inferiority of VNS vaccine (for the 3 pooled lots) compared with varicella vaccine (VV) (for the 2 pooled lots) in terms of seroresponse rate to VZV at Day 43.
• To demonstrate the non-inferiority of VNS vaccine (for the 3 pooled lots) compared with VV (for the 2 pooled lots) in terms of GMC for antibodies to VZV at Day 43.

Secondary objectives 7

1. To demonstrate the non-inferiority of VNS vaccine group (for the 3 pooled lots) compared with VV group (for the 2 pooled lots) in terms of GMCs for antibodies to MMR viruses at Day 43.
2. To evaluate the immunogenicity of VNS vaccine (for the 3 pooled lots) compared with VV (for the 2 pooled lots) in terms of seroresponse rates for antibodies to MMR viruses at Day 43.
3. To demonstrate the non-inferiority of VNS vaccine group (for the 3 pooled lots) compared with VV group (for the 2 pooled lots) in terms of GMC for antibodies to HAV at Day 43 (in HAV subset).
4. To evaluate the immunogenicity of VNS vaccine (for the 3 pooled lots) compared with VV (for the 2 pooled lots) in terms of seroresponse rates for antibodies to HAV at Day 43 (in HAV subset).
5. To demonstrate the non-inferiority of VNS vaccine group (for the 3 pooled lots) compared with VV group (for the 2 pooled lots) in terms of GMCs for antibodies to S. pneumoniae (20 serotypes) at Day 43 [in Pneumococcal conjugate vaccine (PCV) subset)].
6. To demonstrate the non-inferiority of VNS vaccine (for the 3 pooled lots) compared with VV (for the 2 pooled lots) in terms of adaptive seroresponse rate to VZV at Day 43.
7. To evaluate the safety and the reactogenicity following the administration of VNS vaccine and VV when co-administered with MMR vaccine, HAV vaccine, and (if applicable) PCV.

Conditions and MedDRA coding

Varicella

Study design 1 period

Regulatory references

Scientific advice from competent authorities

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

EMA paediatric investigation plan (PIP)

EMEA-003317-PIP02-22

Plan to share IPD

Yes

IPD plan description

No later than 12 months after the last sampling date of the last participant enrolled, GSK will provide investigators with data that may potentially be relevant to the care of their respective participants. This will include the results of the anti-VZV gE ELISA and MMR research immunological assays that the investigator may consider to be indicative of non-responders in the study.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 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).
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 before16 months of age) at the time of the administration of 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. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
3. Hypersensitivity to latex.
4. Major congenital defects, as assessed by the investigator.
5. Recurrent history of uncontrolled neurological disorders or seizures.
6. History of varicella disease.
7. Active untreated tuberculosis
8. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
9. 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 dose of study interventions administration (Day -29 to Day 1), or their planned use during the study period.
10. Planned administration of a vaccine in the period starting 30 days before the dose and ending 43 days after the dose of study interventions administration* (Visit 2) 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. Any other age-appropriate vaccine may be given starting at Visit 2 and anytime thereafter. *If emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is organized by public health authorities outside the routine immunization program, the time period described above can be reduced provided it is used according to the local governmental recommendations and sponsor is notified
11. 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 immune modifying 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.
12. Previous vaccination against measles, mumps, and rubella.
13. Previous vaccination against hepatitis A virus.
14. Previous vaccination against varicella virus.
15. 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.
16. 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).
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: - Immunocompromised individuals. - Pregnant women without documented history of varicella. - Newborn infants of mothers without documented history of varicella. - Newborn infants born less than (<) 28 weeks of gestation.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

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. Time frame: At Day 43
2. Geometric Mean Concentration (GMC) of anti-VZV gE IgG for the 3 lots of VNS vaccine groups. Time 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 group. 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 group. Fime frame: At Day 43.

Secondary endpoints 18

1. Anti-measles antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV group. 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 group. 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 group. 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 group. Time frame: At Day 43.
5. Percentage of participants with seroresponse to anti-mumps for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV group. Time frame: At Day 43
6. Percentage of participants with seroresponse to anti-rubella for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV group. Time frame: At Day 43.
7. Anti-Hepatitis A antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV group in HAV subset. Time frame: At Day 43.
8. Percentage of participants with seroresponse to anti-HAV for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV group in HAV subset. Time frame: At day 43.
9. Anti-S. pneumoniae serotype specific Polysaccharide IgG antibody concentrations for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV group in PCV subset. Time frame: At Day 43.
10. Percentage of participants in the VNS vaccine pooled group with anti-VZV gE antibody concentrations above the adaptive seroresponse threshold. Time frame: At Day 43.
11. Percentage of participants reporting each solicited administration site events (injection site redness, pain and swelling). Time frame: Day 1 (post-dose) to Day 4.
12. Percentage of participants reporting each solicited systemic event (drowsiness, loss of appetite and irritability). Time frame: Day 1 (post-dose) to Day 15.
13. Percentage of participants reporting each solicited systemic event in terms of fever (Fever is defined as temperature greater than or equal to [>=)] 38.0 degrees Celsius [°C] by any route). Time frame: Day 1 (post-dose) to Day 22.
14. Percentage of participants reporting each solicited administration site events (injection site varicella-like rash). Time frame: Day 1 (post-dose) to Day 43.
15. Percentage of participants reporting each solicited systemic events (varicella-like rash [non-injection site] and general rash [not varicella like]). Time frame: Day 1 (post-dose) to Day 43.
16. Percentage of participants reporting unsolicited adverse events (AEs) (any AE reported in addition to solicited events during the study, or any "solicited" symptoms with onset outside of the specified period of follow-up for solicited symptoms). Time frame: Day 1 (post-dose) to Day 43.
17. Percentage of participants reporting medically attended AEs (MAAE) (A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to/by a healthcare professional.). Time frame: Day 1 (post-dose) to Day 181 (study end).
18. Percentage of participants reporting serious adverse events (SAEs). (A SAE is an AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or other situations that are considered serious per medical or scientific judgment.). Time frame: Day 1 (post-dose) to Day 181 (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 15

Locations

4 EU/EEA countries · 17 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 160 files

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

Application history

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