Lot-tot-lot Consistentiestudie van een 21-valent Pneumokokken Conjugaatvaccin bij Gezonde Zuigelingen Vanaf 2 Maanden
Een fase 3, gerandomiseerd, gemodificeerd dubbelblind, actief gecontroleerd, parallelgroep, lot-naar-lot consistentie, 4-arm studie om de veiligheid en immunogeniciteit van een 4-dosis regime van een 21-valent pneumokokkenconjugaatvaccin te onderzoeken bij gezonde zuigelingen en peuters
This is a phase 3 randomized, modified double-blind study whose purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) in a similar way (ie, same immune response) when they are given to infants aged from approximately 2 months (42 to 89 days) and are safe compared to a licensed 20-valent pneumococcal vaccine (20vPCV) (Prevnar 20™).
The study duration per participant will be up to approximately 17 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 months of age. Cohort A will include randomization to three PCV21 formulation groups or one 20vPCV comparator group (Group 1-4, approximately 896 total participants), whereas Cohort B will include randomization to three PCV21 formulation groups only (Groups 1-3, approximately 1299 total participants). Routine pediatric vaccines will be given as per local recommendations.
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, V06 separated from V05 by 30 days
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 3
Contacten en locaties
Studiecontact
- Naam: Trial Transparency email recommended (Toll free for US & Canada)
- Telefoonnummer: option 6 800-633-1610
- E-mail: Contact-US@sanofi.com
Studie Locaties
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San Pedro Sula, Honduras, 21104
- Werving
- Investigational Site Number : 3400001
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Tegucigalpa, Honduras, 11101
- Werving
- Investigational Site Number : 3400003
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Tegucigalpa, Honduras, 11101
- Werving
- Investigational Site Number : 3400002
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Guayama, Puerto Rico, 00786
- Werving
- Investigational Site Number : 6300005
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San Juan, Puerto Rico, 00918
- Werving
- Investigational Site Number : 6300006
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Trujillo Alto, Puerto Rico, 00976
- Werving
- Investigational Site Number : 6300007
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Bangkok, Thailand, 10400
- Werving
- Investigational Site Number : 7640002
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Chiang Mai, Thailand, 50180
- Werving
- Investigational Site Number : 7640004
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Hat Yai, Thailand, 90110
- Werving
- Investigational Site Number : 7640003
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Khon Kaen, Thailand, 40002
- Werving
- Investigational Site Number : 7640001
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Pathum Wan, Thailand, 10330
- Werving
- Investigational Site Number : 7640005
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Arkansas
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Fayetteville, Arkansas, Verenigde Staten, 72703
- Werving
- Northwest Arkansas Pediatric Clinic- Site Number : 8400039
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California
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Huntington Park, California, Verenigde Staten, 90255
- Werving
- Matrix Clinical Research - Huntington Park- Site Number : 8400029
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Los Angeles, California, Verenigde Staten, 90008
- Werving
- Community Clinical Research- Site Number : 8400030
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Los Angeles, California, Verenigde Staten, 90057
- Werving
- Matrix Clinical Research - Los Angeles- Site Number : 8400028
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Florida
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Tampa, Florida, Verenigde Staten, 33613
- Werving
- PAS Research - Tampa- Site Number : 8400034
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Kentucky
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Bardstown, Kentucky, Verenigde Staten, 40004
- Werving
- Kentucky Pediatric Research- Site Number : 8400036
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Michigan
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Allen Park, Michigan, Verenigde Staten, 48101
- Werving
- Michigan Institute of Research- Site Number : 8400004
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New York
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Syracuse, New York, Verenigde Staten, 13210
- Werving
- Nappi Wellness Institute\t- Site Number : 8400037
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South Carolina
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Charleston, South Carolina, Verenigde Staten, 29407
- Werving
- Tribe Clinical Research At Neighbors Pediatrics- Site Number : 8400008
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Simpsonville, South Carolina, Verenigde Staten, 29681
- Werving
- Parkside Pediatrics - Simpsonville- Site Number : 8400005
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Spartanburg, South Carolina, Verenigde Staten, 29301
- Werving
- Tribe Clinical Research - Spartanburg- Site Number : 8400026
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Texas
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Edinburg, Texas, Verenigde Staten, 78539
- Werving
- PAS Research - Children's Care Clinic- Site Number : 8400035
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Richmond, Texas, Verenigde Staten, 77469
- Werving
- Pediatric Center - Richmond- Site Number : 8400038
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Utah
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Ogden, Utah, Verenigde Staten, 84404
- Werving
- Rio Clinical Trials - Canyon View- Site Number : 8400031
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Exclusion Criteria:
- 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 vaccine being administered in the study
- History of seizure or significant stable or progressive neurologic 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 substances3
- Laboratory-confirmed or known thrombocytopenia, as reported by the parent(s) / legally acceptable representative (LAR(s)), 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.
- Receipt of any BCG vaccine within 4 weeks preceding the first study intervention administration or planned receipt any BCG vaccine within the study period
- Previous vaccination against Streptococcus pneumoniae
- Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, H. influenzae type b, 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Group 1: PCV21
Participants will be administered via intramuscular injection (IM) PCV21 vaccine lot 1 for Doses 1, 2 and 3; PCV21 lot 1, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines. |
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Andere namen:
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Experimenteel: Group 2: PCV21
Participants will be administered via IM injection PCV21 vaccine lot 2 for Doses 1, 2 and 3; PCV21 lot 2, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines. |
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Andere namen:
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Experimenteel: Group 3: PCV21
Participants will be administered via IM injection PCV21 vaccine lot 3 for Doses 1, 2 and 3; PCV21 lot 3, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines. |
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Andere namen:
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Actieve vergelijker: Group 4: 20vPCV (Cohort A only)
Participants will be administered via IM injection 20vPCV at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines. |
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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For all participants: Serotype specific Immunoglobulin g (IgG) Geometric Mean Concentration (GMC)
Tijdsspanne: 30 days after the third dose of PCV21 vaccine
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Serotype specific IgG concentrations for all serotypes included in PCV21 vaccine as measured by electrochemiluminescence assay (ECL) |
30 days after the third dose of PCV21 vaccine
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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For all participants: Serotype specific IgG concentration ≥ 0.35 µg/mL
Tijdsspanne: 30 days after the third dose of PCV21 vaccine
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Serotype specific IgG concentration ≥ 0.35 μg/mL (seroresponse) for all serotypes included in PCV21 as measured by ECL |
30 days after the third dose of PCV21 vaccine
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For all participants: Presence of any immediate adverse events (AEs)
Tijdsspanne: Within 30 minutes after each vaccine injection
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Number of participants experiencing immediate AEs |
Within 30 minutes after each vaccine injection
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For participants in Cohort A (reactogenicity subset): Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection
Tijdsspanne: Through 7 days after each vaccine injection
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Number of participants experiencing solicited injection site and systemic reactions |
Through 7 days after each vaccine injection
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For all participants: Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs
Tijdsspanne: Through 30 days after each vaccine injection
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Number of participants experiencing unsolicited injection site reactions and unsolicited systemic AEs |
Through 30 days after each vaccine injection
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For all participants: Presence of serious adverse events (SAEs) and adverse events of special interest (AESIs) throughout the study
Tijdsspanne: Throughout the study (through 6 months post-last vaccine injection)
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Number of participants experiencing SAEs and AESIs |
Throughout the study (through 6 months post-last vaccine injection)
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PSK00029
- PSK00029 (Andere identificatie: Sanofi Identifier)
- U1111-1308-6832 (Andere identificatie: WHO ICTRP)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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