Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
- Conditions
- Pneumococcal Immunization
- Interventions
- Biological: PCV21 vaccineBiological: Prevnar 20 vaccineBiological: M-M-R II vaccineBiological: Hexaxim Vaccine
- Registration Number
- NCT06736041
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1630
- 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
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2: 20vPCV RotaTeq 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. Group 2: 20vPCV Varivax 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. Group 1: PCV21 RotaTeq 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. Group 1: PCV21 Varivax 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. Group 1: PCV21 PCV21 vaccine 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. Group 1: PCV21 M-M-R II vaccine 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. Group 1: PCV21 Vaxelis vaccine 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. Group 1: PCV21 Hexaxim Vaccine 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. Group 2: 20vPCV Prevnar 20 vaccine 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. Group 2: 20vPCV M-M-R II vaccine 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. Group 2: 20vPCV Vaxelis vaccine 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. Group 2: 20vPCV Hexaxim Vaccine 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.
- Primary Outcome Measures
Name Time Method Seroresponse rate for PCV21 serotypes 30 days post-dose 3 Serotype specific IgG concentration ≥ 0.35 µg/mL
IgG concentration for PCV21 serotypes 30 days post-dose 4 Serotype specific IgG GMC post-dose 4
- Secondary Outcome Measures
Name Time Method Anti- hepatitis B surface antigen (HBsAg) Ab 30 days post-dose 3 % Antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL)
Anti- polyribosylribitol phosphate (PRP) Ab 30 days post-dose 3 % Antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL)
Anti-poliovirus types (1, 2, and 3) Ab 30 days post-dose 3 % Antibody titers ≥ 1:8
Anti-diphtheria Ab concentrations 30 days post-dose 3 % Antibody concentrations ≥ 0.1 IU/mL
Anti-tetanus Ab concentrations 30 days post-dose 3 % Antibody concentrations ≥ 0.1 IU/mL
Anti-pertussis Ab concentrations (Pertussis toxin (PT) and Filamentous Hemagglutinin (FHA)) 30 days post-dose 3 Antibody GMC
Anti-rotavirus serum immunoglobulin A (IgA) Ab concentrations 30 days post-dose 3 Antibody GMC
Anti-measles Ab concentrations 30 days post-dose 4 Antibody GMC
Anti-mumps Ab concentrations 30 days post-dose 4 Antibody GMC
Anti-rubella Ab concentrations 30 days post-dose 4 Antibody GMC
Anti-varicella Ab concentrations 30 days post-dose 4 Anti-varicella Ab concentrations ≥ 5 glycoprotein enzyme linked immunosorbent assay (gpELISA) units/mL
IgG concentration for the additional serotype 9N 30 days post-dose 3 Serotype 9N specific IgG concentration ≥ 0.35 µg/mL
IgG concentration for serotype 3 30 days post-dose 4 Serotype 3 specific IgG GMC post-dose 4
IgG concentration for additional serotype 9N 30 days post-dose 4 Serotype 9N specific IgG GMC post-dose 4
Serotype specific OPA titers for all serotypes included in PCV21 Before dose 4 and 30 days post-dose 4 Antibody GMC prior to and post-dose 4
Presence of any immediate adverse events (AEs) Within 30 minutes after each vaccine injection Number of participants experiencing solicited and unsolicited immediate AEs
Presence of serious adverse events (SAEs) throughout the study (through 6 months post- last vaccine injection) Throughout the study (through 6 months post-last vaccine injection), approximately 20 months Number of participants experiencing SAEs
Serotype 9N specific IgG GMC post-dose 4 30 days post-dose 4 Serotype 9N specific IgG GMC post-dose 4
Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection Through 7 days after each vaccine injection Number of participants experiencing solicited injection site and systemic reactions
Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs through 30 days after each vaccine injection Through 30 days after each vaccine injection Number of participants experiencing unsolicited injection site reactions and unsolicited systemic AEs
Seroresponse rate for PCV21 serotypes 30 days post-dose 4 Serotype specific IgG concentration ≥ 0.35 µg/mL
IgG concentration for PCV21 serotypes Before dose 4 and 30 days post-dose 4 Serotype specific IgG GMC prior to and post-dose 4
Serotype specific OPA titers ≥ lower limit of quantitation (LLOQ) for all serotypes included in PCV21 Before dose 4 and 30 days post-dose 4 Antibody GMC prior to and post-dose 4
Related Research Topics
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Trial Locations
- Locations (70)
Eclipse Clinical Research- Site Number : 8400029
🇺🇸Tucson, Arizona, United States
Northwest Arkansas Pediatrics- Site Number : 8400030
🇺🇸Fayetteville, Arkansas, United States
Century Research Institute- Site Number : 8400065
🇺🇸Huntington Park, California, United States
Matrix Clinical Research - Huntington Park- Site Number : 8400012
🇺🇸Huntington Park, California, United States
Chemidox Clinical Trials- Site Number : 8400026
🇺🇸Lancaster, California, United States
Matrix Clinical Research - Los Angeles- Site Number : 8400013
🇺🇸Los Angeles, California, United States
Carey Chronis, MD, FAAP- Site Number : 8400063
🇺🇸Ventura, California, United States
Velocity Clinical Research - Washington DC- Site Number : 8400049
🇺🇸Washington, District of Columbia, United States
PAS Research- Site Number : 8400123
🇺🇸Clearwater, Florida, United States
Prohealth Research Center- Site Number : 8400159
🇺🇸Doral, Florida, United States
Bio Research Partner- Site Number : 8400203
🇺🇸Miami Lakes, Florida, United States
Bingham Memorial Hospital - Blackfoot- Site Number : 8400084
🇺🇸Blackfoot, Idaho, United States
Dade Research Center- Site Number : 8400007
🇺🇸Miami, Florida, United States
Riveldi Biomedical Research and Associates - Miami- Site Number : 8400032
🇺🇸Miami, Florida, United States
Acevedo Clinical Research Associates- Site Number : 8400089
🇺🇸Miami, Florida, United States
Bio-Medical Research- Site Number : 8400147
🇺🇸Miami, Florida, United States
SEC Clinical Research- Site Number : 8400003
🇺🇸Pensacola, Florida, United States
PAS Research- Site Number : 8400002
🇺🇸Tampa, Florida, United States
Leavitt Women's Healthcare- Site Number : 8400085
🇺🇸Idaho Falls, Idaho, United States
Snake River Research- Site Number : 8400060
🇺🇸Idaho Falls, Idaho, United States
Alliance for Multispeciality Research - El Dorado- Site Number : 8400010
🇺🇸El Dorado, Kansas, United States
Hutchinson Clinic, P.A.- Site Number : 8400061
🇺🇸Hutchinson, Kansas, United States
Cotton O'Neil Clinical Research-Pediatrics- Site Number : 8400009
🇺🇸Topeka, Kansas, United States
Dayton Clinical Research- Site Number : 8400087
🇺🇸Dayton, Ohio, United States
Tribe Clinical Research - Greenville - Verdae Boulevard- Site Number : 8400005
🇺🇸Greenville, South Carolina, United States
Coastal Carolina Research Center - North Charleston- Site Number : 8400064
🇺🇸North Charleston, South Carolina, United States
Inquest Clinical Research- Site Number : 8400112
🇺🇸Baytown, Texas, United States
KeyPoint Clinical Research- Site Number : 8400173
🇺🇸Dallas, Texas, United States
Ventavia Research Group - Fort Worth- Site Number : 8400072
🇺🇸Fort Worth, Texas, United States
Ventavia Research Group - Houston - North Loop West- Site Number : 8400093
🇺🇸Houston, Texas, United States
Gonzalez Research Institute- Site Number : 8400035
🇺🇸Houston, Texas, United States
Maximos Ob/Gyn- Site Number : 8400056
🇺🇸League City, Texas, United States
Pediatric Center - Richmond- Site Number : 8400068
🇺🇸Richmond, Texas, United States
Wasatch Pedicatrics- Site Number : 8400153
🇺🇸Murray, Utah, United States
Rio Clinical Trials, LLC- Site Number : 8400222
🇺🇸Ogden, Utah, United States
Investigational Site Number : 0360001
🇦🇺Westmead, New South Wales, Australia
Investigational Site Number : 0360004
🇦🇺Brisbane, Queensland, Australia
Investigational Site Number : 0360005
🇦🇺Southport, Queensland, Australia
Investigational Site Number : 0360002
🇦🇺Parkville, Victoria, Australia
Investigational Site Number : 0360003
🇦🇺Nedlands, Western Australia, Australia
Investigational Site Number : 3400001
🇭🇳San Pedro Sula, Honduras
Investigational Site Number : 3400002
🇭🇳Tegucigalpa, Honduras
Investigational Site Number : 3400003
🇭🇳Tegucigalpa, Honduras
Investigational Site Number : 4100023
🇰🇷Busan, Busan-gwangyeoksi, Korea, Republic of
Investigational Site Number : 4100030
🇰🇷Daegu, Daegu-gwangyeoksi, Korea, Republic of
Investigational Site Number : 4100029
🇰🇷Bucheon, Gyeonggi-do, Korea, Republic of
Investigational Site Number : 4100001
🇰🇷Seongnam, Gyeonggi-do, Korea, Republic of
Investigational Site Number : 4100010
🇰🇷Yangsan, Gyeongsangnam-do, Korea, Republic of
Investigational Site Number : 4100004
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100009
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100026
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 6300004
🇵🇷Caguas, Puerto Rico
Investigational Site Number : 4100024
🇰🇷Daegu, Daegu-gwangyeoksi, Korea, Republic of
Investigational Site Number : 4100034
🇰🇷Gwangju, Gwangju-gwangyeoksi, Korea, Republic of
Investigational Site Number : 4100002
🇰🇷Anyang, Gyeonggi-do, Korea, Republic of
Investigational Site Number : 4100019
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100015
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 6300008
🇵🇷Guayama, Puerto Rico
Investigational Site Number : 6300003
🇵🇷Ponce, Puerto Rico
Investigational Site Number : 6300002
🇵🇷San Juan, Puerto Rico
Investigational Site Number : 4100013
🇰🇷Bucheon, Gyeonggi-do, Korea, Republic of
Investigational Site Number : 4100027
🇰🇷Changwon, Gyeongsangnam-do, Korea, Republic of
Investigational Site Number : 4100014
🇰🇷Hwaseong, Gyeonggi-do, Korea, Republic of
Investigational Site Number : 4100025
🇰🇷Jeonju, Jeollabuk-do, Korea, Republic of
Investigational Site Number : 4100005
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100006
🇰🇷Incheon, Incheon-gwangyeoksi, Korea, Republic of
Investigational Site Number : 4100031
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100008
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100003
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 6300005
🇵🇷Trujillo Alto, Puerto Rico