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Clinical Trial of PCV13 in Infants Aged Approximately 2 Months (42 to 89 Days)

11. Mai 2026 aktualisiert von: Sinovac Life Sciences Co., Ltd.

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

Noch keine Rekrutierung

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

Interventionell

Einschreibung (Geschätzt)

500

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

    • Cavite
      • Imus, Cavite, Philippinen
        • Health Index Multispecialty Clinic (HIMC) Research and Development on Medical Sciences
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

Inclusion Criteria:

  1. Health infants aged approximately 2 months (42 to 89 days)
  2. Have a parent/legal guardian who has provided written informed consent after being fully informed about the study.
  3. Be able to provide the vaccination records since birth.
  4. 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:

  1. Previous vaccination of any licensed or investigational pneumococcal vaccine, or planned receipt during the study participation;
  2. Previous vaccination of vaccines containing the component of diphtheria, tetanus, pertussis, poliomyelitis, and/or Hib vaccine.
  3. Previous receipt of ≥2 doses of hepatitis B vaccine; or receipt of a single hepatitis B vaccine dose administered at >30 days old.
  4. History of severe adverse reaction to previous vaccinations and/or serious allergic reactions (eg, anaphylaxis) to any vaccine component.
  5. History of any laboratory confirmed pneumococcal bacterial pneumonia or invasive pneumococcal diseases caused by S pneumoniae.
  6. Premature infants (born before week 37 of gestation).
  7. Severe congenital malformations, developmental disorders, clinically significant genetic defects, malnutrition.
  8. Autoimmune diseases or immunodeficiency/immunosuppression.
  9. Serious chronic diseases such as Down's syndrome, diabetes, sickle cell anemia, or neurological disorders.
  10. Abnormal coagulation functions (e.g., coagulation factor deficiency, blood coagulation diseases, platelet disorders).
  11. 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.
  12. Received blood products before investigational vaccine inoculation, or plan to receive these treatments during study participation.
  13. Received other investigational drugs/vaccines before enrollment, or plan to receive investigational drugs/vaccines during study participation.
  14. Received live attenuated vaccines or nucleic-acid vaccines within 14 days before enrollment.
  15. Received subunit or inactivated vaccines within 7 days before enrollment.
  16. Acute diseases or acute exacerbations of chronic diseases within 7 days before enrollment.
  17. Axillary temperature ≥ 37.5°C before enrollment.
  18. Any other factors judged by the investigators as unsuitable for participation.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
One dose of Sinovac PCV13 (0.5ml) was administered at 2, 4, and 12-15 months of age.
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.
One dose of Prevenar 13™ (0.5ml) was administered at 2, 4, and 12-15 months of age.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of participants with pneumococcal serotype-specific IgG antibody concentrations≥0.35 μg/mL .
Zeitfenster: 30 days after dose 2.
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.
30 days after dose 2.
Geometric mean concentrations (GMCs) of serotype-specific IgG antibody.
Zeitfenster: 30 days after dose 2
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.
30 days after dose 2

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Häufigkeit von Nebenwirkungen
Zeitfenster: 0–7 Tage nach jeder Dosis
Auftreten von Nebenwirkungen innerhalb von 7 Tagen nach jeder Dosis
0–7 Tage nach jeder Dosis
Percentage of participants with pneumococcal serotype-specific IgG antibody concentrations≥0.35 μg/mL .
Zeitfenster: 30 days after dose 3.
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.
30 days after dose 3.
Geometric mean concentrations (GMCs ) of serotype-specific IgG antibody.
Zeitfenster: 30 days after dose 3.
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.
30 days after dose 3.
Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL
Zeitfenster: 30 days after dose 2
Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL at 30 days after dose 2
30 days after dose 2
Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL .
Zeitfenster: 30 days after dose 3
Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL at 30 days after dose 3.
30 days after dose 3
GMC fold increases (GMFRs) in IgG antibody concentrations.
Zeitfenster: From before dose 3 to 30 days after dose 3
GMC fold increases (GMFRs) in IgG antibody concentrations from before dose 3 to 30 days after dose 3.
From before dose 3 to 30 days after dose 3
Percentage of participants with serotype-specific opsonophagocytosis assay (OPA) antibody titers ≥1:8
Zeitfenster: 30 days after the dose 2.
Percentage of participants with serotype-specific OPA antibody titers ≥1:8 at 30 days after the dose 2.
30 days after the dose 2.
Percentage of participants with serotype-specific OPA antibody titers ≥1:8.
Zeitfenster: 30 days after the dose 3.
Percentage of participants with serotype-specific OPA antibody titers ≥1:8 at 30 days after the dose 3.
30 days after the dose 3.
Geometric mean titers (GMTs) of serotype-specific OPA antibody.
Zeitfenster: 30 days after dose 2.
Geometric mean titers (GMTs) of serotype-specific OPA antibody 30 days after dose 2.
30 days after dose 2.
GMTs of serotype-specific OPA antibody .
Zeitfenster: 30 days after dose 3.
GMTs of serotype-specific OPA antibody at 30 days after dose 3.
30 days after dose 3.
GMT fold rises (GMFRs) in OPA titers.
Zeitfenster: From before dose 3 to 30 days after dose 3.
GMT fold rises (GMFRs) in OPA titers from before dose 3 to 30 days after dose 3.
From before dose 3 to 30 days after dose 3.
Incidence of adverse reactions
Zeitfenster: 0-30 days after each dose.
Incidence of adverse reactions within 30 days after each dose.
0-30 days after each dose.
Incidence of serious adverse events(SAEs)
Zeitfenster: From dose 1 to 30 days after dose 3
Incidence of SAEs from dose 1 to 30 days after dose 3
From dose 1 to 30 days after dose 3
Percentage of infants with anti-diphtheria toxoid IgG concentrations ≥ 0.1 IU/mL
Zeitfenster: 30 days after dose 3 of DTwP-HepB-Hib
Percentage of infants with anti-diphtheria toxoid IgG concentrations ≥ 0.1 IU/mL at 30 days after dose 3 of DTwP-HepB-Hib
30 days after dose 3 of DTwP-HepB-Hib
Percentage of infants with anti-tetanus toxoid IgG concentrations ≥ 0.1 IU/mL
Zeitfenster: 30 days after dose 3 of DTwP-HepB-Hib
Percentage of infants with anti-tetanus toxoid IgG concentrations ≥ 0.1 IU/mL at 30 days after dose 3 of DTwP-HepB-Hib
30 days after dose 3 of DTwP-HepB-Hib
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
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
30 days after dose 3 of DTwP-HepB-Hib
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
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
30 days after dose 3 of DTwP-HepB-Hib
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
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
30 days after dose 3 of DTwP-HepB-Hib
Percentage of infants with anti-poliovirus types 1, 2 and 3 neutralizing antibody titers≥1:8
Zeitfenster: 30 days after dose 3 of IPV
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
30 days after dose 3 of IPV

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Edison Alberto, Health Index Multispecialty Clinic (HIMC) Research and Development on Medical Sciences

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Mai 2026

Primärer Abschluss (Geschätzt)

1. Juli 2027

Studienabschluss (Geschätzt)

1. Juli 2027

Studienanmeldedaten

Zuerst eingereicht

11. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. Mai 2026

Zuerst gepostet (Tatsächlich)

18. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. Mai 2026

Zuletzt verifiziert

1. Mai 2026

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

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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