A study on the immune response and safety of an investigational chickenpox vaccine and a marketed measles, mumps and rubella vaccine when administered as intramuscular injection 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 Dec 2025 → ongoing

Decision date (initial)

2025-08-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

GlaxoSmithKline Biologicals

External identifiers

EU CT number

2024-518840-18-00

ClinicalTrials.gov

NCT06855160

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis, Others, Safety

To demonstrate the non-inferiority of the intramuscular administration of VNS vaccine compared to subcutaneous administration of VV in terms of seroresponse rate to VZV at Day 43

To demonstrate the non-inferiority of the intramuscular administration of VNS vaccine compared to subcutaneous administration of VV in terms of GMC for antibodies to VZV at Day 43.

To demonstrate the non-inferiority of intramuscular administration of MMR vaccine compared to subcutaneous administration in terms of seroresponse rate to MMR at Day 43.

To demonstrate the non-inferiority of intramuscular administration of MMR vaccine compared to subcutaneous administration in terms of GMC for antibodies to MMR at Day 43.

Secondary objectives 3

1. To demonstrate an acceptable immune response for intramuscular administration of MMR vaccine in terms of seroresponse rate to MMR at Day 43.
2. To demonstrate the non-inferiority of intramuscular administration of MMR vaccine compared to subcutaneous administration in terms of seroresponse rate to MMR at Day 43 with a reduced non-inferiority margin.
3. To evaluate safety and reactogenicity following intramuscular administration of VNS and MMR vaccines, and subcutaneous administration of VV and MMR vaccines when co-administered with HAV vaccine and (if applicable) PCV.

Conditions and MedDRA coding

Varicella

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

Federal Agency For Medicines And Health Products, European Medicines Agency, 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)/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 the administration of study intervention.

Exclusion criteria 20

1. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions including hypersensitivity to neomycin or gelatin.
2. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
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 measles, mumps, rubella, or varicella disease.
7. Active untreated tuberculosis.
8. Participants with bleeding disorders (e.g., thrombocytopenia or any coagulation disorder).
9. Condition that in the judgment of the investigator would make intramuscular injection unsafe.
10. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
11. 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.
12. 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.
13. Previous vaccination against measles, mumps, and rubella.
14. Previous vaccination against varicella virus.
15. Previous vaccination against hepatitis A virus.
16. 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.
17. 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)
18. Any study personnel or their immediate dependents, family, or household members.
19. Child in care. Please see DEFINITIONS OF TERMS for the definition of child in care.
20. 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 <28 weeks of gestation.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Seroresponse to VZV gE at Day 43.
2. Anti-VZV gE IgG concentration at Day 43.
3. Seroresponse to MMR antigens at Day 43.
4. Anti-measles, anti-mumps, and anti-rubella IgG concentration at Day 43.

Secondary endpoints 9

1. Seroresponse to MMR antigens at Day 43.
2. Percentage of participants reporting each solicited administration site event in terms of injection site redness, pain, and swelling within 4 days (Day 1 to Day 4) post-dose of VNS vaccine or VV administration.
3. Percentage of participants reporting each solicited administration site event in terms of injection site redness, pain, and swelling within 4 days (Day 1 to Day 4) post-dose of MMR vaccine administration.
4. Percentage of participants reporting each solicited systemic event in terms of drowsiness, loss of appetite, and irritability within 15 days (Day 1 to Day 15) post-dose of study interventions administration.
5. Percentage of participants reporting each solicited systemic event in terms of fever within 22 days (Day 1 to Day 22) post-dose of study interventions administration.
6. Percentage of participants reporting each solicited administration site and systemic event in terms of injection site varicella-like rash, varicella-like rash (non-injection site), measles/rubella-like rash, and general rash (not varicella-like and not measles/rubella like) within 43 days (Day 1 to Day 43) post dose of study interventions administration as assessed by the investigator
7. Unsolicited adverse events (AEs) • Percentage of participants reporting unsolicited AEs within 43 days (Day 1 to Day 43) post-dose of study interventions administration.
8. Medically attended AEs (MAAEs) • Percentage of participants reporting MAAEs from Day 1 post-dose of study interventions administration up to study end (Day 181).
9. Serious adverse events (SAEs) • Percentage of participants reporting SAEs from Day 1 post-dose of study interventions administration up to study end (Day 181)

Investigational products

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

Test 4

Comparator 3

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

Derek Moriarty

Third parties 14

Locations

8 EU/EEA countries · 24 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 355 files

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

Application history

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