Clinical trial NCT06736041: Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pneumococcal Immunization
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-12-16
Enrollment: 1630
Sex: ALL
Minimum age (years): 42
Maximum age (years): 89
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a Phase 3, randomized, modified double-blind study which aims to measure whether PCV21 vaccine (investigational pneumococcal conjugate vaccine) is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) compared with 20-valent pneumococcal vaccine (Prevnar 20, licensed pneumococcal conjugate vaccine) when they are administered with routine pediatric vaccines in infants aged from approximately 2 months (42 to 89 days).

The study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20-valent pneumococcal vaccines) will be administered at approximately 2, 4, 6 and 12 to 15 months of age. Routine pediatric vaccines will be given at the same timepoints.

There will be 6 study visits:

-Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age until 15 months of age, V06 separated from V05 by 30 days.


Eligibility criteria: 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

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.

Primary outcomes:
measure: Seroresponse rate for PCV21 serotypes
timeFrame: 30 days post-dose 3
measure: IgG concentration for PCV21 serotypes
timeFrame: 30 days post-dose 3
measure: IgG concentration for PCV21 serotypes
timeFrame: 30 days post-dose 4
Secondary outcomes:
measure: Anti- hepatitis B surface antigen (HBsAg) Ab
timeFrame: 30 days post-dose 3
measure: Anti- polyribosylribitol phosphate (PRP) Ab
timeFrame: 30 days post-dose 3
measure: Anti-poliovirus types (1, 2, and 3) Ab
timeFrame: 30 days post-dose 3
measure: Anti-diphtheria Ab concentrations
timeFrame: 30 days post-dose 3
measure: Anti-tetanus Ab concentrations
timeFrame: 30 days post-dose 3
measure: Anti-pertussis Ab concentrations (Pertussis toxin (PT) and Filamentous Hemagglutinin (FHA))
timeFrame: 30 days post-dose 3
measure: Anti-rotavirus serum immunoglobulin A (IgA) Ab concentrations
timeFrame: 30 days post-dose 3
measure: Anti-measles Ab concentrations
timeFrame: 30 days post-dose 4
measure: Anti-measles Ab concentrations
timeFrame: 30 days post-dose 4
measure: Anti-mumps Ab concentrations
timeFrame: 30 days post-dose 4
measure: Anti-mumps Ab concentrations
timeFrame: 30 days post-dose 4
measure: Anti-rubella Ab concentrations
timeFrame: 30 days post-dose 4
measure: Anti-rubella Ab concentrations
timeFrame: 30 days post-dose 4
measure: Anti-varicella Ab concentrations
timeFrame: 30 days post-dose 4
measure: IgG concentration for the additional serotype 9N
timeFrame: 30 days post-dose 3
measure: IgG concentration for serotype 3
timeFrame: 30 days post-dose 3
measure: IgG concentration for additional serotype 9N
timeFrame: 30 days post-dose 3
measure: IgG concentration for serotype 3
timeFrame: 30 days post-dose 3
measure: Serotype 9N specific IgG GMC post-dose 4
timeFrame: 30 days post-dose 4
measure: IgG concentration for additional serotype 9N
timeFrame: 30 days post-dose 4
measure: IgG concentration for serotype 3
timeFrame: 30 days post-dose 4
measure: Seroresponse rate for PCV21 serotypes
timeFrame: 30 days post-dose 4
measure: IgG concentration for PCV21 serotypes
timeFrame: Before dose 4 and 30 days post-dose 4
measure: Serotype specific OPA titers for all serotypes included in PCV21
timeFrame: 30 days post-dose 3
measure: Serotype specific OPA titers ≥ lower limit of quantitation (LLOQ) for all serotypes included in PCV21
timeFrame: 30 days post-dose 3
measure: Serotype specific OPA titers for all serotypes included in PCV21
timeFrame: Before dose 4 and 30 days post-dose 4
measure: Serotype specific OPA titers ≥ lower limit of quantitation (LLOQ) for all serotypes included in PCV21
timeFrame: Before dose 4 and 30 days post-dose 4
measure: Presence of any immediate adverse events (AEs)
timeFrame: Within 30 minutes after each vaccine injection
measure: Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection
timeFrame: Through 7 days after each vaccine injection
measure: Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs through 30 days after each vaccine injection
timeFrame: Through 30 days after each vaccine injection
measure: Presence of serious adverse events (SAEs) throughout the study (through 6 months post- last vaccine injection)
timeFrame: Throughout the study (through 6 months post-last vaccine injection), approximately 20 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Eclipse Clinical Research- Site Number : 8400029
state: Arizona
city: Fayetteville
country: United States
facility: Northwest Arkansas Pediatrics- Site Number : 8400030
state: Arkansas
city: Huntington Park
country: United States
facility: Century Research Institute- Site Number : 8400065
state: California
city: Huntington Park
country: United States
facility: Matrix Clinical Research - Huntington Park- Site Number : 8400012
state: California
city: Lancaster
country: United States
facility: Chemidox Clinical Trials- Site Number : 8400026
state: California
city: Los Angeles
country: United States
facility: Matrix Clinical Research - Los Angeles- Site Number : 8400013
state: California
city: Ventura
country: United States
facility: Carey Chronis, MD, FAAP- Site Number : 8400063
state: California
city: Washington
country: United States
facility: Velocity Clinical Research - Washington DC- Site Number : 8400049
state: District of Columbia
city: Clearwater
country: United States
facility: PAS Research- Site Number : 8400123
state: Florida
city: Doral
country: United States
facility: Prohealth Research Center- Site Number : 8400159
state: Florida
city: Miami Lakes
country: United States
facility: Bio Research Partner- Site Number : 8400203
state: Florida
city: Miami
country: United States
facility: Dade Research Center- Site Number : 8400007
state: Florida
city: Miami
country: United States
facility: Riveldi Biomedical Research and Associates - Miami- Site Number : 8400032
state: Florida
city: Miami
country: United States
facility: Acevedo Clinical Research Associates- Site Number : 8400089
state: Florida
city: Miami
country: United States
facility: Bio-Medical Research- Site Number : 8400147
state: Florida
city: Pensacola
country: United States
facility: SEC Clinical Research- Site Number : 8400003
state: Florida
city: Tampa
country: United States
facility: PAS Research- Site Number : 8400002
state: Florida
city: Blackfoot
country: United States
facility: Bingham Memorial Hospital - Blackfoot- Site Number : 8400084
state: Idaho
city: Idaho Falls
country: United States
facility: Leavitt Women's Healthcare- Site Number : 8400085
state: Idaho
city: Idaho Falls
country: United States
facility: Snake River Research- Site Number : 8400060
state: Idaho
city: El Dorado
country: United States
facility: Alliance for Multispeciality Research - El Dorado- Site Number : 8400010
state: Kansas
city: Hutchinson
country: United States
facility: Hutchinson Clinic, P.A.- Site Number : 8400061
state: Kansas
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research-Pediatrics- Site Number : 8400009
state: Kansas
city: Dayton
country: United States
facility: Dayton Clinical Research- Site Number : 8400087
state: Ohio
city: Erie
country: United States
facility: Allegheny Health Network - Health and Wellness Pavilion- Site Number : 8400111
state: Pennsylvania
city: Greenville
country: United States
facility: Tribe Clinical Research - Greenville - Verdae Boulevard- Site Number : 8400005
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research Center - North Charleston- Site Number : 8400064
state: South Carolina
city: Baytown
country: United States
facility: Inquest Clinical Research- Site Number : 8400112
state: Texas
city: Dallas
country: United States
facility: KeyPoint Clinical Research- Site Number : 8400173
state: Texas
city: Fort Worth
country: United States
facility: Ventavia Research Group - Fort Worth- Site Number : 8400072
state: Texas
city: Houston
country: United States
facility: Ventavia Research Group - Houston - North Loop West- Site Number : 8400093
state: Texas
city: Houston
country: United States
facility: Gonzalez Research Institute- Site Number : 8400035
state: Texas
city: League City
country: United States
facility: Maximos Ob/Gyn- Site Number : 8400056
state: Texas
city: Richmond
country: United States
facility: Pediatric Center - Richmond- Site Number : 8400068
state: Texas
city: Murray
country: United States
facility: Wasatch Pedicatrics- Site Number : 8400153
state: Utah
city: Ogden
country: United States
facility: Rio Clinical Trials, LLC- Site Number : 8400222
state: Utah
city: Westmead
country: Australia
facility: Investigational Site Number : 0360001
state: New South Wales
city: Brisbane
country: Australia
facility: Investigational Site Number : 0360004
state: Queensland
city: Southport
country: Australia
facility: Investigational Site Number : 0360005
state: Queensland
city: Parkville
country: Australia
facility: Investigational Site Number : 0360002
state: Victoria
city: Nedlands
country: Australia
facility: Investigational Site Number : 0360003
state: Western Australia
city: San Pedro Sula
country: Honduras
facility: Investigational Site Number : 3400001
city: Tegucigalpa
country: Honduras
facility: Investigational Site Number : 3400002
city: Tegucigalpa
country: Honduras
facility: Investigational Site Number : 3400003
city: Busan
country: Korea, Republic of
facility: Investigational Site Number : 4100023
state: Busan-gwangyeoksi
city: Daegu
country: Korea, Republic of
facility: Investigational Site Number : 4100030
state: Daegu-gwangyeoksi
city: Daegu
country: Korea, Republic of
facility: Investigational Site Number : 4100024
state: Daegu-gwangyeoksi
city: Gwangju
country: Korea, Republic of
facility: Investigational Site Number : 4100034
state: Gwangju-gwangyeoksi
city: Ansan
country: Korea, Republic of
facility: Investigational Site Number : 4100020
state: Gyeonggi-do
city: Anyang
country: Korea, Republic of
facility: Investigational Site Number : 4100002
state: Gyeonggi-do
city: Bucheon
country: Korea, Republic of
facility: Investigational Site Number : 4100013
state: Gyeonggi-do
city: Bucheon
country: Korea, Republic of
facility: Investigational Site Number : 4100029
state: Gyeonggi-do
city: Hwaseong
country: Korea, Republic of
facility: Investigational Site Number : 4100014
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
facility: Investigational Site Number : 4100001
state: Gyeonggi-do
city: Changwon
country: Korea, Republic of
facility: Investigational Site Number : 4100027
state: Gyeongsangnam-do
city: Yangsan
country: Korea, Republic of
facility: Investigational Site Number : 4100010
state: Gyeongsangnam-do
city: Incheon
country: Korea, Republic of
facility: Investigational Site Number : 4100017
state: Incheon-gwangyeoksi
city: Incheon
country: Korea, Republic of
facility: Investigational Site Number : 4100006
state: Incheon-gwangyeoksi
city: Jeonju
country: Korea, Republic of
facility: Investigational Site Number : 4100025
state: Jeollabuk-do
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100019
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100008
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100005
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100004
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100009
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100015
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100007
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100031
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100003
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100026
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100022
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100018
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100016
state: Seoul-teukbyeolsi
city: Caguas
country: Puerto Rico
facility: Investigational Site Number : 6300004
city: Guayama
country: Puerto Rico
facility: Investigational Site Number : 6300008
city: Ponce
country: Puerto Rico
facility: Investigational Site Number : 6300003
city: San Juan
country: Puerto Rico
facility: Investigational Site Number : 6300002
city: Trujillo Alto
country: Puerto Rico
facility: Investigational Site Number : 6300005
Study officials:
References: