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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06736041




Registration number
NCT06736041
Ethics application status
Date submitted
11/12/2024
Date registered
16/12/2024

Titles & IDs
Public title
Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
Scientific title
A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 2-arm Study to Investigate the Safety and Immunogenicity of a 4-dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers
Secondary ID [1] 0 0
U1111-1294-7860
Secondary ID [2] 0 0
PSK03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumococcal Immunization 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - PCV21 vaccine
Treatment: Other - Prevnar 20 vaccine
Treatment: Other - M-M-R II vaccine
Treatment: Other - RotaTeq
Treatment: Other - Vaxelis vaccine
Treatment: Other - Varivax
Treatment: Other - Hexaxim Vaccine

Experimental: Group 1: PCV21 - Participants will be administered via intramuscular injection (IM) a 3-dose primary series of PCV21 at approximately 2, 4 and 6 months of age (MoA) co- administered with Vaxelis or Hexaxim (for participants included in South Korea only) and RotaTeq. At toddler age (12 to 15 MoA), a 4th dose of PCV21 will be administered concomitantly with a single dose of M-M-M-R II and Varivax.

Active comparator: Group 2: 20vPCV - Participants will be administered via intramuscular injection (IM) a 3-dose primary series of 20vPCV at approximately 2, 4 and 6 months of age (MoA) co- administered with Vaxelis or Hexaxim (for participants included in South Korea only) and RotaTeq. At toddler age (12 to 15 MoA), a 4th dose of 20vPCV will be administered concomitantly with a single dose of M-M-M-R II and Varivax.


Treatment: Other: PCV21 vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Treatment: Other: Prevnar 20 vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Treatment: Other: M-M-R II vaccine
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular

Treatment: Other: RotaTeq
Pharmaceutical form:Solution-Route of administration:Oral

Treatment: Other: Vaxelis vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Treatment: Other: Varivax
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular

Treatment: Other: Hexaxim Vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Seroresponse rate for PCV21 serotypes
Timepoint [1] 0 0
30 days post-dose 3
Primary outcome [2] 0 0
IgG concentration for PCV21 serotypes
Timepoint [2] 0 0
30 days post-dose 3
Primary outcome [3] 0 0
IgG concentration for PCV21 serotypes
Timepoint [3] 0 0
30 days post-dose 4
Secondary outcome [1] 0 0
Anti- hepatitis B surface antigen (HBsAg) Ab
Timepoint [1] 0 0
30 days post-dose 3
Secondary outcome [2] 0 0
Anti- polyribosylribitol phosphate (PRP) Ab
Timepoint [2] 0 0
30 days post-dose 3
Secondary outcome [3] 0 0
Anti-poliovirus types (1, 2, and 3) Ab
Timepoint [3] 0 0
30 days post-dose 3
Secondary outcome [4] 0 0
Anti-diphtheria Ab concentrations
Timepoint [4] 0 0
30 days post-dose 3
Secondary outcome [5] 0 0
Anti-tetanus Ab concentrations
Timepoint [5] 0 0
30 days post-dose 3
Secondary outcome [6] 0 0
Anti-pertussis Ab concentrations (Pertussis toxin (PT) and Filamentous Hemagglutinin (FHA))
Timepoint [6] 0 0
30 days post-dose 3
Secondary outcome [7] 0 0
Anti-rotavirus serum immunoglobulin A (IgA) Ab concentrations
Timepoint [7] 0 0
30 days post-dose 3
Secondary outcome [8] 0 0
Anti-measles Ab concentrations
Timepoint [8] 0 0
30 days post-dose 4
Secondary outcome [9] 0 0
Anti-measles Ab concentrations
Timepoint [9] 0 0
30 days post-dose 4
Secondary outcome [10] 0 0
Anti-mumps Ab concentrations
Timepoint [10] 0 0
30 days post-dose 4
Secondary outcome [11] 0 0
Anti-mumps Ab concentrations
Timepoint [11] 0 0
30 days post-dose 4
Secondary outcome [12] 0 0
Anti-rubella Ab concentrations
Timepoint [12] 0 0
30 days post-dose 4
Secondary outcome [13] 0 0
Anti-rubella Ab concentrations
Timepoint [13] 0 0
30 days post-dose 4
Secondary outcome [14] 0 0
Anti-varicella Ab concentrations
Timepoint [14] 0 0
30 days post-dose 4
Secondary outcome [15] 0 0
IgG concentration for the additional serotype 9N
Timepoint [15] 0 0
30 days post-dose 3
Secondary outcome [16] 0 0
IgG concentration for serotype 3
Timepoint [16] 0 0
30 days post-dose 3
Secondary outcome [17] 0 0
IgG concentration for additional serotype 9N
Timepoint [17] 0 0
30 days post-dose 3
Secondary outcome [18] 0 0
IgG concentration for serotype 3
Timepoint [18] 0 0
30 days post-dose 3
Secondary outcome [19] 0 0
Serotype 9N specific IgG GMC post-dose 4
Timepoint [19] 0 0
30 days post-dose 4
Secondary outcome [20] 0 0
IgG concentration for additional serotype 9N
Timepoint [20] 0 0
30 days post-dose 4
Secondary outcome [21] 0 0
IgG concentration for serotype 3
Timepoint [21] 0 0
30 days post-dose 4
Secondary outcome [22] 0 0
Seroresponse rate for PCV21 serotypes
Timepoint [22] 0 0
30 days post-dose 4
Secondary outcome [23] 0 0
IgG concentration for PCV21 serotypes
Timepoint [23] 0 0
Before dose 4 and 30 days post-dose 4
Secondary outcome [24] 0 0
Serotype specific OPA titers for all serotypes included in PCV21
Timepoint [24] 0 0
30 days post-dose 3
Secondary outcome [25] 0 0
Serotype specific OPA titers = lower limit of quantitation (LLOQ) for all serotypes included in PCV21
Timepoint [25] 0 0
30 days post-dose 3
Secondary outcome [26] 0 0
Serotype specific OPA titers for all serotypes included in PCV21
Timepoint [26] 0 0
Before dose 4 and 30 days post-dose 4
Secondary outcome [27] 0 0
Serotype specific OPA titers = lower limit of quantitation (LLOQ) for all serotypes included in PCV21
Timepoint [27] 0 0
Before dose 4 and 30 days post-dose 4
Secondary outcome [28] 0 0
Presence of any immediate adverse events (AEs)
Timepoint [28] 0 0
Within 30 minutes after each vaccine injection
Secondary outcome [29] 0 0
Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection
Timepoint [29] 0 0
Through 7 days after each vaccine injection
Secondary outcome [30] 0 0
Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs through 30 days after each vaccine injection
Timepoint [30] 0 0
Through 30 days after each vaccine injection
Secondary outcome [31] 0 0
Presence of serious adverse events (SAEs) throughout the study (through 6 months post- last vaccine injection)
Timepoint [31] 0 0
Throughout the study (through 6 months post-last vaccine injection), approximately 20 months

Eligibility
Key inclusion criteria
* Aged 42 to 89 days on the day of inclusion
* Participants who are healthy as determined by medical evaluation including medical history and physical examination
* Born at full term of pregnancy (= 37 weeks) and with a birth weight = 2.5 kg or born after a gestation period above 28 (> 28 weeks) through 36 weeks with a birth weight = 1.5 kg, and in both cases medically stable as assessed by the investigator
Minimum age
42 Days
Maximum age
89 Days
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants are excluded from the study if any of the following criteria apply:

* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy
* History of microbiologically confirmed Streptococcus pneumoniae infection or disease
* Any contraindication to the routine pediatric vaccines being administered in the study
* History of seizure or significant stable or progressive neurological disorders such as infantile spasms, inflammatory nervous system diseases, encephalopathy, cerebral palsy
* Known systemic hypersensitivity to any of the study interventions components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
* Laboratory-confirmed or known thrombocytopenia, as reported by the parent/legally acceptable representative (LAR), contraindicating intramuscular (IM) injection
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection
* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
* Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature = 38.0°C [= 100.4°F]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
* Receipt of any vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine in the 4 weeks following the study intervention administration, except for US licensed influenza vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines, as applicable per local recommendations.
* Previous vaccination against S. pneumoniae
* Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and poliovirus
* Receipt of more than 1 dose of hepatitis B vaccine
* Receipt of immune globulins, blood or blood-derived products since birth
* Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure

Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
16/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/05/2027
Actual
Sample size
Target
1630
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Investigational Site Number : 0360001 - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi Pasteur, a Sanofi Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
Contact-US@sanofi.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06736041