A study on the 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

10 Jun 2025 → ongoing

Decision date (initial)

2025-05-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

GlaxoSmithKline Biologicals

External identifiers

EU CT number

2024-515868-31-00

ClinicalTrials.gov

NCT06693895

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis, Safety

To evaluate safety and reactogenicity following administration of VNS vaccine and VV when co-administered with MMR vaccine, HAV vaccine, and (if applicable) PCV.

Conditions and MedDRA coding

Varicella

Regulatory references

Scientific advice from competent authorities

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

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)/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 before 16 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 16

1. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
2. Previous vaccination against measles, mumps, and rubella.
3. Previous vaccination against hepatitis A virus.
4. Previous vaccination against varicella virus.
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 a booster dose of any PCV.
6. 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).
7. Active untreated tuberculosis.
8. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
9. Hypersensitivity to latex.
10. Recurrent history of uncontrolled neurological disorders or seizures.
11. History of varicella disease.
12. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
13. 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.
14. 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.
15. 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.
16. Other exclusion criteria may apply as per the study Protocol.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Occurrence of solicited: •administration site events within 4 days (Day 1 to Day 4) post dose of VNS vaccine or VV administration. •systemic events within 15 days (Day 1 to Day 15) post-dose of study interventions administration. •systemic event (fever) within 22 days (Day 1 to Day 22) post-dose of study interventions administration. •administration site and systemic events (rash) within 43 days (Day 1 to Day 43) post-dose of study interventions administration.
2. Occurrence of any unsolicited AEs within 43 days (Day 1 to Day 43) post-dose of study interventions administration.
3. Occurrence of any medically attended AEs post-dose of study interventions administration up to study end (Day 181).
4. Occurrence of SAEs post-dose of study interventions administration up to 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 5

Locations

5 EU/EEA countries · 18 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 190 files

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

Application history

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