Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Can we Reduce the Number of Vaccine Injections for Children? (MALTA)

6 november 2015 bijgewerkt door: University of Oxford

An Open Label Randomised Controlled Study to Evaluate the Induction of Immune Memory Following Infant Vaccination With a Glycoconjugate Neisseria Meningitidis Serogroup C Vaccine and to Assess the Immunological Impact of Administering Routine Infant Immunisations in Consistent Versus Alternating Limbs

This open label randomised controlled study will evaluate the induction of immunity following varying schedules of vaccination with glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccines in infancy. 498 infants will be enrolled in this multi-centre trial. Participants will receive either 0, 1, or 2 priming doses of a MenC-CRM197 conjugate vaccine or 1 priming dose of a MenC-TT conjugate vaccine in the first year of life, with all groups receiving a dose of a combination Hib-MenC-TT vaccine at 12 months, as well as all other concurrent routine vaccinations. All groups will also be further divided into 2 groups to receive their routine vaccines in either consistent or alternating limbs to assess the immune response to the concurrent infant routine immunisations administered in consistent versus alternating limbs. Immune responses will be assessed at 5, 12, 12months +6 days, 13 and 24 months of age.

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Werkelijk)

404

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

2 maanden tot 3 maanden (Kind)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Healthy male or female infants aged 6-12 weeks at the time of the first vaccination and who were born between 37 and 42 weeks of gestation
  • Infants who are known to be free from medical problems as determined by a medical history and clinical examination
  • Parents or guardians who are willing for their child to participate and who would be expected to comply with the requirements of the protocol
  • Parents/guardians who have given informed consent for their child's participation in the study

Exclusion Criteria:

  • History of invasive meningococcal C disease
  • Previous vaccination against meningococcal serogroup C disease
  • Planned administration/administration of vaccines, since birth, other than the study vaccines (with the exception of oral rotavirus vaccine, Hepatitis B vaccine and BCG).
  • Receipt of investigational vaccines/drugs, other than the vaccines used in the study, within 30 days prior to receiving the first dose of the vaccines or their planned use during the study period
  • Confirmed or suspected immunosuppressive or immunodeficient conditions, including human immunodeficiency virus (HIV) infection.
  • A family history of congenital or hereditary immunodeficiency.
  • Receipt of more than 2 weeks of immunosuppressants or immune modifying drugs, (e.g. prednisolone >0.5mg/kg/day)
  • History of allergy to any component of the vaccines.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures
  • Acute disease at the time of recruitment as defined by the presence of a moderate or severe illness with or without fever (with the exception of minor illnesses such as diarrhoea, mild upper respiratory infection without fever). In such situations enrolment should be postponed until the participant has recovered.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
  • Parents who plan to move out of the geographical area where the study would be conducted.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Two Dose MenC Group
Two doses of MenC-CRM197 priming at 3 and 4 months of age.

In order to ensure proper intramuscular injection of the study vaccines, a 23G (0.5mm in diameter) needle of at least 1 inch (2.54 cm) length will be used. All vaccines will be administered intramuscularly.

Then MenC vaccine will administered either once (at 3 months) or twice (at 3 and 4 months) depending on treatment group to either the thigh, deltoid or a combination of the two.

Routine schedule immunisations will be given according to NHS guidelines.
Experimenteel: Single Dose MenC-CRM197 Group
One dose of MenC-CRM197 priming at 3 months of age.

In order to ensure proper intramuscular injection of the study vaccines, a 23G (0.5mm in diameter) needle of at least 1 inch (2.54 cm) length will be used. All vaccines will be administered intramuscularly.

Then MenC vaccine will administered either once (at 3 months) or twice (at 3 and 4 months) depending on treatment group to either the thigh, deltoid or a combination of the two.

Routine schedule immunisations will be given according to NHS guidelines.
Experimenteel: Single Dose MenC-TT Group
Single dose MenC-TT priming at 3 months of age

In order to ensure proper intramuscular injection of the study vaccines, a 23G (0.5mm in diameter) needle of at least 1 inch (2.54 cm) length will be used. All vaccines will be administered intramuscularly.

Then MenC vaccine will administered either once (at 3 months) or twice (at 3 and 4 months) depending on treatment group to either the thigh, deltoid or a combination of the two.

Routine schedule immunisations will be given according to NHS guidelines.
Experimenteel: Control Group
Zero dose MenC priming
Routine schedule immunisations will be given according to NHS guidelines.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Geometric mean titres (GMTs) of meningococcal serogroup C (MenC) specific serum bactericidal antibodies, using rabbit complement (rSBA)
Tijdsspanne: 1 month after a 12 month dose of Hib-MenC vaccine
To demonstrate non-inferiority of the geometric mean titres (GMTs) of meningococcal serogroup C (MenC) specific serum bactericidal antibodies, using rabbit complement (rSBA), 1 month after a 12 month dose of Hib-MenC vaccine in children receiving a single dose of MenC-CRM197vaccine at 3 months of age (single dose priming) compared with those receiving 2 doses at 3 and 4 months of age (2 dose priming).
1 month after a 12 month dose of Hib-MenC vaccine

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juni 2010

Primaire voltooiing (Werkelijk)

1 juli 2013

Studieregistratiedata

Eerst ingediend

21 mei 2010

Eerst ingediend dat voldeed aan de QC-criteria

21 mei 2010

Eerst geplaatst (Schatting)

24 mei 2010

Updates van studierecords

Laatste update geplaatst (Schatting)

9 november 2015

Laatste update ingediend die voldeed aan QC-criteria

6 november 2015

Laatst geverifieerd

1 november 2015

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccine

3
Abonneren