- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07593924
Clinical Trial of PCV13 in Infants Aged Approximately 2 Months (42 to 89 Days)
A Phase III, Randomized, Double-blind, Active Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine Administered as a Series of 2 Infant Doses and 1 Toddler Dose in Healthy Infants
A Phase III clinical trial of 13-valent pneumococcal conjugate vaccine (PCV13)developed by Sinovac Life Science Co., Ltd will be conducted in infants aged approximately 2 months (42 to 89 days).
The objective of the study is to evaluate the immunogenicity and safety of Sinovac PCV13. The trial is a randomized, double-blind, active controlled phase III clinical trial.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
A phase III clinical trial of the study of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13) developed by Sinovac Life Science Co., Ltd (Sinovac) will be conducted in Philippines infants aged approximately 2 months (42 to 89 days).
The trial is a randomized, double-blind, active controlled study. The objective of this study is to evaluate the immunogenicity and safety of PCV13 manufactured by Sinovac Life Science Co., Ltd. The active control vaccine is Prevenar 13™ manufactured by Pfizer.
About 500 infants aged approximately 2 months (42 to 89 days) will be enrolled. Participants will be randomized in 1:1 ratio to the test group and control group.
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 3
Kontakte und Standorte
Studienkontakt
- Name: Edison Alberto
- Telefonnummer: (046)471-0996/+639171490841
- E-Mail: edisonalberto@rocketmail.com
Studienorte
-
-
Cavite
-
Imus, Cavite, Philippinen
- Health Index Multispecialty Clinic (HIMC) Research and Development on Medical Sciences
-
Kontakt:
- Edison R. Alberto
- Telefonnummer: (046)471-0996/+639171490841
- E-Mail: edisonalberto@rocketmail.com
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Health infants aged approximately 2 months (42 to 89 days)
- Have a parent/legal guardian who has provided written informed consent after being fully informed about the study.
- Be able to provide the vaccination records since birth.
- The infant's mother is tested negative for HIV, syphilis, hepatitis B, and hepatitis C before the infant's enrollment to this study (test results obtained during pregnancy are acceptable, if provided).
Exclusion Criteria:
- Previous vaccination of any licensed or investigational pneumococcal vaccine, or planned receipt during the study participation;
- Previous vaccination of vaccines containing the component of diphtheria, tetanus, pertussis, poliomyelitis, and/or Hib vaccine.
- Previous receipt of ≥2 doses of hepatitis B vaccine; or receipt of a single hepatitis B vaccine dose administered at >30 days old.
- History of severe adverse reaction to previous vaccinations and/or serious allergic reactions (eg, anaphylaxis) to any vaccine component.
- History of any laboratory confirmed pneumococcal bacterial pneumonia or invasive pneumococcal diseases caused by S pneumoniae.
- Premature infants (born before week 37 of gestation).
- Severe congenital malformations, developmental disorders, clinically significant genetic defects, malnutrition.
- Autoimmune diseases or immunodeficiency/immunosuppression.
- Serious chronic diseases such as Down's syndrome, diabetes, sickle cell anemia, or neurological disorders.
- Abnormal coagulation functions (e.g., coagulation factor deficiency, blood coagulation diseases, platelet disorders).
- Received immunosuppressive for ≥14 days (e.g., prednisone equivalent of ≥2 mg/kg), or cytotoxic drug before enrollment, or plans to receive these treatments during the study participation.
- Received blood products before investigational vaccine inoculation, or plan to receive these treatments during study participation.
- Received other investigational drugs/vaccines before enrollment, or plan to receive investigational drugs/vaccines during study participation.
- Received live attenuated vaccines or nucleic-acid vaccines within 14 days before enrollment.
- Received subunit or inactivated vaccines within 7 days before enrollment.
- Acute diseases or acute exacerbations of chronic diseases within 7 days before enrollment.
- Axillary temperature ≥ 37.5°C before enrollment.
- Any other factors judged by the investigators as unsuitable for participation.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Sinovac PCV 13
250 participants aged 2 months (42 to 89 days) will receive 3 doses of Sinovac PCV13 at approximately 2, 4 and 12-15 months of age.Route of administration is intramuscular injection at anterolateral thigh for infants aged younger than 12 months, and at deltoid muscle of upper arm for children aged older than 12 months.
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One dose of Sinovac PCV13 (0.5ml) was administered at 2, 4, and 12-15 months of age.
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Aktiver Komparator: Prevenar 13™
250 participants aged 2 months (42 to 89 days) will receive 3 doses of Prevenar 13™ at approximately 2, 4 and 12-15 months of age.Route of administration is intramuscular injection at anterolateral thigh for infants aged younger than 12 months, and at deltoid muscle of upper arm for children aged older than 12 months.
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One dose of Prevenar 13™ (0.5ml) was administered at 2, 4, and 12-15 months of age.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Percentage of participants with pneumococcal serotype-specific IgG antibody concentrations≥0.35 μg/mL .
Zeitfenster: 30 days after dose 2.
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Non-inferiority criterion: The lower limit of the two-sided 95% CI for the difference (Sinovac-PCV13 minus Prevenar 13™) > -10% for each serotype at 30 days after dose 2.
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30 days after dose 2.
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Geometric mean concentrations (GMCs) of serotype-specific IgG antibody.
Zeitfenster: 30 days after dose 2
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Non-inferiority criterion: The lower limit of the two-sided 95% CI for the GMC ratio (Sinovac-PCV13/Prevenar 13™) > 0.5 for each serotype at 30 days after dose 2.
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30 days after dose 2
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Häufigkeit von Nebenwirkungen
Zeitfenster: 0–7 Tage nach jeder Dosis
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Auftreten von Nebenwirkungen innerhalb von 7 Tagen nach jeder Dosis
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0–7 Tage nach jeder Dosis
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Percentage of participants with pneumococcal serotype-specific IgG antibody concentrations≥0.35 μg/mL .
Zeitfenster: 30 days after dose 3.
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Non-inferiority criterion: The lower limit of the two-sided 95% CI for the difference (Sinovac-PCV13 minus Prevenar 13™) > -10% for each serotype at 30 days after dose 3.
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30 days after dose 3.
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Geometric mean concentrations (GMCs ) of serotype-specific IgG antibody.
Zeitfenster: 30 days after dose 3.
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Non-inferiority criterion: The lower limit of the two-sided 95% CI for the GMC ratio (Sinovac-PCV13/Prevenar 13™) > 0.5 for each serotype at 30 days after dose 3.
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30 days after dose 3.
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Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL
Zeitfenster: 30 days after dose 2
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Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL at 30 days after dose 2
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30 days after dose 2
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Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL .
Zeitfenster: 30 days after dose 3
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Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL at 30 days after dose 3.
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30 days after dose 3
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GMC fold increases (GMFRs) in IgG antibody concentrations.
Zeitfenster: From before dose 3 to 30 days after dose 3
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GMC fold increases (GMFRs) in IgG antibody concentrations from before dose 3 to 30 days after dose 3.
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From before dose 3 to 30 days after dose 3
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Percentage of participants with serotype-specific opsonophagocytosis assay (OPA) antibody titers ≥1:8
Zeitfenster: 30 days after the dose 2.
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Percentage of participants with serotype-specific OPA antibody titers ≥1:8 at 30 days after the dose 2.
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30 days after the dose 2.
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Percentage of participants with serotype-specific OPA antibody titers ≥1:8.
Zeitfenster: 30 days after the dose 3.
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Percentage of participants with serotype-specific OPA antibody titers ≥1:8 at 30 days after the dose 3.
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30 days after the dose 3.
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Geometric mean titers (GMTs) of serotype-specific OPA antibody.
Zeitfenster: 30 days after dose 2.
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Geometric mean titers (GMTs) of serotype-specific OPA antibody 30 days after dose 2.
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30 days after dose 2.
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GMTs of serotype-specific OPA antibody .
Zeitfenster: 30 days after dose 3.
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GMTs of serotype-specific OPA antibody at 30 days after dose 3.
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30 days after dose 3.
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GMT fold rises (GMFRs) in OPA titers.
Zeitfenster: From before dose 3 to 30 days after dose 3.
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GMT fold rises (GMFRs) in OPA titers from before dose 3 to 30 days after dose 3.
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From before dose 3 to 30 days after dose 3.
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Incidence of adverse reactions
Zeitfenster: 0-30 days after each dose.
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Incidence of adverse reactions within 30 days after each dose.
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0-30 days after each dose.
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Incidence of serious adverse events(SAEs)
Zeitfenster: From dose 1 to 30 days after dose 3
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Incidence of SAEs from dose 1 to 30 days after dose 3
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From dose 1 to 30 days after dose 3
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Percentage of infants with anti-diphtheria toxoid IgG concentrations ≥ 0.1 IU/mL
Zeitfenster: 30 days after dose 3 of DTwP-HepB-Hib
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Percentage of infants with anti-diphtheria toxoid IgG concentrations ≥ 0.1 IU/mL at 30 days after dose 3 of DTwP-HepB-Hib
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30 days after dose 3 of DTwP-HepB-Hib
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Percentage of infants with anti-tetanus toxoid IgG concentrations ≥ 0.1 IU/mL
Zeitfenster: 30 days after dose 3 of DTwP-HepB-Hib
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Percentage of infants with anti-tetanus toxoid IgG concentrations ≥ 0.1 IU/mL at 30 days after dose 3 of DTwP-HepB-Hib
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30 days after dose 3 of DTwP-HepB-Hib
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Percentage of participants achieving an anti-acellular pertussis (PT, FHA and PRN antigens) antibody concentration
Zeitfenster: 30 days after dose 3 of DTwP-HepB-Hib
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Percentage of participants achieving an anti-acellular pertussis (PT, FHA and PRN antigens) antibody concentration ≥ the observed anti-pertussis antibody concentration achieved by 95% of Prevenar 13™ recipients at 30 days after dose 3 of DTwP-HepB-Hib
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30 days after dose 3 of DTwP-HepB-Hib
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Percentage of infants with anti-Haemophilus influenzae type b (PRP) IgG concentration≥0.15 µg/mL
Zeitfenster: 30 days after dose 3 of DTwP-HepB-Hib
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Percentage of infants with anti-Haemophilus influenzae type b (PRP) IgG concentration≥0.15
µg/mL at 30 days after dose 3 of DTwP-HepB-Hib
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30 days after dose 3 of DTwP-HepB-Hib
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Percentage of infants with anti-Hepatitis B surface antigen (HBsAg) antibody concentrations≥10 mIU/mL
Zeitfenster: 30 days after dose 3 of DTwP-HepB-Hib
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Percentage of infants with anti-Hepatitis B surface antigen (HBsAg) antibody concentrations≥10 mIU/mL at 30 days after dose 3 of DTwP-HepB-Hib
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30 days after dose 3 of DTwP-HepB-Hib
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Percentage of infants with anti-poliovirus types 1, 2 and 3 neutralizing antibody titers≥1:8
Zeitfenster: 30 days after dose 3 of IPV
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Percentage of infants with anti-poliovirus types 1, 2 and 3 neutralizing antibody titers≥1:8 measured at 30 days after dose 3 of IPV
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30 days after dose 3 of IPV
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Edison Alberto, Health Index Multispecialty Clinic (HIMC) Research and Development on Medical Sciences
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- PRO-PCV13-3003
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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