A Phase 2 Partially Observer-Blind Randomized Controlled Multicenter Dose-Ranging and Formulation-Finding Study of a New Novartis Meningococcal B Recombinant Vaccine Evaluating the Safety and Immunogenicity When Given Concomitantly With Routine Vaccines in 2-month-old Infants

CompletadoFase 2ClinicalTrials.gov

ID: NCT00937521Tipo: INTERVENTIONALInicio: 1 de jul de 2009Fin estimado: 1 de feb de 2012

Traducción no disponible, mostrando original

Resumen

This study is aimed at assessing the safety and immunogenicity of different doses and formulations of a new Novartis Meningococcal B Recombinant Vaccine.

Elegibilidad

Edad mínima: 55 DaysEdad máxima: 89 DaysSexo: ALL

Criterios de inclusión

Healthy 2-month old infants (55-89 days, inclusive), born after full term pregnancy, gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg
Available for all the visits scheduled in the study and for whom a parent/legal guardian is willing/able to comply with all protocol requirements

Criterios de exclusión

Any meningococcal B or C vaccine administration
Prior vaccination with any Diphtheria, Tetanus, Pertussis (acellular or whole cell), Polio (either Inactivated or Oral), Haemophilus influenzae type b (Hib), and Pneumococcal antigens;
Any ascertained or suspected disease caused by N. meningitidis
Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis
History of severe allergic reaction after previous vaccinations
Recent significant acute or chronic infection
Oral or parenteral antibiotic treatment in the 7 days prior to the scheduled blood draw;
Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition)
Any impairment/alteration of the immune system resulting from (for example):
Receipt of any immunosuppressive therapy at any time since birth
Receipt of immunostimulants at any time since birth
Use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids at any time since birth
Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation
Participation in another clinical trial
Family members and household members of research staff
History of seizure
Any contraindication to paracetamol

Intervenciones

biological

Meningococcal B vaccine

Vaccine candidate formulation I

biological

Meningococcal B vaccine

Vaccine candidate formulation II

biological

Meningococcal B vaccine

Vaccine candidate formulation III

biological

Meningococcal B vaccine

Vaccine candidate formulation IV

biological

Meningococcal B vaccine

Vaccine candidate formulation V

biological

Meningococcal B vaccine

Vaccine candidate formulation VI

biological

Control

biological

Meningococcal B vaccine with antipyretic

Vaccine candidate formulation I with antipyretic

Ubicaciones

Hospital Privado de Córdoba CMC SA

Naciones Unidas 346, Córdoba Province, Argentina

Patrocinadores

PrincipalNovartis Vaccines

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Phase 2 Partially Observer-Blind Randomized Controlled ... | EligiMed