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Concomitant Use of Hepatitis A Vaccine, Inactivated With Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Given to Healthy Children 15 Months of Age (V251-068)

16. März 2017 aktualisiert von: Merck Sharp & Dohme LLC

An Open, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of VAQTA™ Given Concomitantly With PedvaxHIB™ and Infanrix™ in Healthy Children 15 Months of Age

This two-stage study evaluates the immunogenicity, safety, and tolerability of the administration of VAQTA™ (Hepatitis A Vaccine, Inactivated) concomitantly with PedvaxHIB™ (Haemophilus B Conjugate Vaccine [Meningococcal Protein Conjugate]) and Infanrix™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, GlaxoSmithKline) versus the administration of VAQTA™ in healthy children 15 months of age at study entry.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

In stage I, VAQTA™ given concomitantly with Infanrix™ and/or PedvaxHIB™ was evaluated.

In stage 2: Two (2) doses of the VAQTA™ vaccine were administered at least 6 months apart. Safety data was collected after each dose.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

1274

Phase

  • Phase 4

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

1 Jahr bis 1 Jahr (Kind)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Stage 1) Healthy males and females 15 months of age with no active liver disease and a negative history of hepatitis A who have been vaccinated against Haemophilus influenzae type b (Hib), diphtheria, tetanus, and pertussis diseases
  • Stage 2) Healthy males and females 12 to 17 months of age with no active liver disease and a negative history of hepatitis A

Exclusion Criteria:

  • Stage 1) Males and females previously vaccinated with hepatitis A vaccine, any immune deficiency, a history of allergy to any of the vaccine components, a history of seizure disorder or a neurologic disorder that would contraindicate pertussis vaccine, or a bleeding disorder
  • Stage 2) Males and females previously vaccinated with hepatitis A vaccine, any immune deficiency, a history of allergy to any of the vaccine components, or a history of bleeding disorder

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: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: VAQTA™, PedvaxHIB™ and Infanrix™/VAQTA™ (Stage 1)

Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.

Week 24: The second dose of VAQTA™ was administered.
Biologisch: Comparator: VAQTA™

VAQTA™ (Hepatitis A Vaccine, Inactivated).

Two intramuscular 0.5-mL doses of VAQTA™ were administered 24 weeks apart, with the second dose being administered prior to 24 months of age.

Biologisch: Comparator: Infanrix™

Infanrix™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis

Vaccine Adsorbed, GlaxoSmithKline).

One intramuscular 0.5-mL injection of Infanrix™ was administered at the first study visit.

Biologisch: Comparator: PedvaxHIB™

PedvaxHIB™ (Haemophilus B Conjugate Vaccine [Meningococcal Protein Conjugate]).

One intramuscular 0.5-mL injection of PedvaxHIB™ was administered at the first study visit.

Andere Namen:
  • One intramuscular 0.5-mL injection of PedvaxHIB™ was administered to all subjects at the first study
  • visit in all treatment groups in the study.
Experimental: PedvaxHIB™ and Infanrix™/VAQTA™/VAQTA™ (Stage 1)

Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.

Week 4: The first dose of VAQTA™ was administered.

Week 28: The second dose of VAQTA™ was administered.
Biologisch: Comparator: VAQTA™

VAQTA™ (Hepatitis A Vaccine, Inactivated).

Two intramuscular 0.5-mL doses of VAQTA™ were administered 24 weeks apart, with the second dose being administered prior to 24 months of age.

Biologisch: Comparator: Infanrix™

Infanrix™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis

Vaccine Adsorbed, GlaxoSmithKline).

One intramuscular 0.5-mL injection of Infanrix™ was administered at the first study visit.

Biologisch: Comparator: PedvaxHIB™

PedvaxHIB™ (Haemophilus B Conjugate Vaccine [Meningococcal Protein Conjugate]).

One intramuscular 0.5-mL injection of PedvaxHIB™ was administered at the first study visit.

Andere Namen:
  • One intramuscular 0.5-mL injection of PedvaxHIB™ was administered to all subjects at the first study
  • visit in all treatment groups in the study.
Experimental: VAQTA™, PedvaxHIB™/VAQTA™ (Stage 1)

Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.

Week 24: The second dose of VAQTA™ was administered.
Biologisch: Comparator: VAQTA™

VAQTA™ (Hepatitis A Vaccine, Inactivated).

Two intramuscular 0.5-mL doses of VAQTA™ were administered 24 weeks apart, with the second dose being administered prior to 24 months of age.

Biologisch: Comparator: PedvaxHIB™

PedvaxHIB™ (Haemophilus B Conjugate Vaccine [Meningococcal Protein Conjugate]).

One intramuscular 0.5-mL injection of PedvaxHIB™ was administered at the first study visit.

Andere Namen:
  • One intramuscular 0.5-mL injection of PedvaxHIB™ was administered to all subjects at the first study
  • visit in all treatment groups in the study.
Experimental: PedvaxHIB™/VAQTA™/VAQTA™ (Stage 1)

Day 1: PedvaxHIB™ was administered.

Week 4: The first dose of VAQTA™ was administered.

Week 28: The second dose of VAQTA™ was administered.
Biologisch: Comparator: VAQTA™

VAQTA™ (Hepatitis A Vaccine, Inactivated).

Two intramuscular 0.5-mL doses of VAQTA™ were administered 24 weeks apart, with the second dose being administered prior to 24 months of age.

Biologisch: Comparator: PedvaxHIB™

PedvaxHIB™ (Haemophilus B Conjugate Vaccine [Meningococcal Protein Conjugate]).

One intramuscular 0.5-mL injection of PedvaxHIB™ was administered at the first study visit.

Andere Namen:
  • One intramuscular 0.5-mL injection of PedvaxHIB™ was administered to all subjects at the first study
  • visit in all treatment groups in the study.
Experimental: VAQTA™/VAQTA™ (Stage 2)

Day 1: The first dose of VAQTA™ was administered.

Week 24: The second dose of VAQTA™ was administered.
Biologisch: Comparator: VAQTA™

VAQTA™ (Hepatitis A Vaccine, Inactivated).

Two intramuscular 0.5-mL doses of VAQTA™ were administered 24 weeks apart, with the second dose being administered prior to 24 months of age.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Seropositivity Rate (SPR) to Hepatitis A
Zeitfenster: 4 weeks after dose 2 of VAQTA™
SPR is the percent of participants with Hepatitis A antibody titers >= 10 milli-International Units/milliliter (mIU/mL), 4 weeks after dose 2 of VAQTA™ regardless of their initial serostatus. Antibody titers to Hepatitis A virus (HAV) were detected in participants' serum samples using an Enzyme Immunoassay (EIA).
4 weeks after dose 2 of VAQTA™
Antibody Response Rate to Haemophilus Influenzae Type b (Hib)
Zeitfenster: 4 weeks postvaccination with PedvaxHIB™

Antibodies to the Hib capsular polysaccharide (polyribosylribitol phosphate [PRP]) are assessed in participants serum using radioimmunoassay (RIA). The limit of detection (LOD) for the RIA is 6.60 ng/mL.

The antibody response rate is defined as the percentage of participants with anti-PRP titers >1.0 mcg/mL, 4 weeks postvaccination with PedvaxHIB™.
4 weeks postvaccination with PedvaxHIB™
Number of Participants With Adverse Events (AE)
Zeitfenster: Days 1 to 14 after any dose of VAQTA™ for systemic AEs, and Days 1 to 5 after any dose of VAQTA™ for injection-site AEs

Systemic and injection site AEs were collected from participants receiving

  • VAQTA™ concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ (Stage I)
  • VAQTA™ non-concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ (Stage I)
  • VAQTA™ administered alone (Stage II)

Safety data was collected on a standardized Vaccination Report Card (VRC)

following each dose. Participants returned the VRC after the safety follow-up period for each dose of VAQTA™. AEs determined by the investigator to be possibly, probably or definitely related to the vaccine are reported as Vaccine-related AE.
Days 1 to 14 after any dose of VAQTA™ for systemic AEs, and Days 1 to 5 after any dose of VAQTA™ for injection-site AEs
Geometric Mean Titers (GMTs) to Antibodies for the Pertussis Toxin (PT), Pertussis Filamentous Hemagglutinin Antibody (FHA), and Pertactin (PRN) Components of Infanrix™
Zeitfenster: 4 weeks postvaccination with Infanrix™

GMTs for antibodies to PT, FHA, and PRN were measured in serum samples of participants vaccinated with Infanrix™.

IgG antibodies to PT were assessed using the anti-pertussis toxin enzyme-linked immunosorbent assay (anti-PT ELISA), with the LOD of 2.4 ELU/mL.

IgG antibodies to FHA were assessed using the anti-pertussis filamentous hemagglutinin enzyme-linked immunosorbent assay (anti-FHA ELISA), with the LOD of 2.0 ELU/mL.

IgG antibodies to PRN were assessed using the anti-pertussis pertactin enzyme-linked immunosorbent assay (anti-PRN ELISA), with the LOD of 3.3 ELU/mL.
4 weeks postvaccination with Infanrix™

Mitarbeiter und Ermittler

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

Sponsor

Merck Sharp & Dohme LLC

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

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

1. April 2006

Primärer Abschluss (Tatsächlich)

1. Juni 2010

Studienabschluss (Tatsächlich)

1. Juni 2010

Studienanmeldedaten

Zuerst eingereicht

8. Februar 2006

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Februar 2006

Zuerst gepostet (Schätzen)

10. Februar 2006

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. April 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. März 2017

Zuletzt verifiziert

1. März 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • V251-068
  • 2005_076

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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