Clinical trial NCT00798304: Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants
Official title: An Open Label, Randomized, Phase 1/2 Trial Of The Safety, Tolerability, And Immunogenicity Of Meningococcal Group B Rlp2086 Vaccine In Healthy Infants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Meningitis, Meningococcal
Keywords: Meningococcal B vaccine
infants
safety
immunogenicity
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-26
Enrollment: 46
Sex: ALL
Minimum age (years): 42
Maximum age (years): 98
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B vaccine in healthy infants.


Eligibility criteria: Inclusion Criteria:

* Investigators should always use good clinical judgment in considering a subject's overall fitness for trial participation. In addition, any condition that in the opinion of the investigator may interfere with the evaluation of study objectives should be carefully considered prior to enrolling subjects.
* Male or female subjects aged 2 months (42 to 98 days of age) at the time of enrollment.
* Available for the entire consented period and whose parent/legal guardian can be reached by telephone.
* Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
* Parent/legal guardian must be able to complete all relevant study procedures during study participation.

Exclusion Criteria:

* Previous vaccination with licensed or investigational vaccines: meningococcal B, meningococcal C, pneumococcal, Hib, diphtheria, tetanus, acellular pertussis, poliovirus, rotavirus, varicella, measles, mumps, or rubella.

Any of the following illnesses/conditions that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study:

* A previous anaphylactic reaction to any vaccine or vaccine-related component.
* Contraindication to vaccination with meningococcal B, meningococcal C, pneumococcal, Hib, diphtheria, tetanus, acellular pertussis, Hepatitis B (HBV), poliovirus, rotavirus, varicella, measles, mumps, or rubella.
* Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
* Known or suspected immune deficiency or suppression.
* History of culture-proven invasive disease caused by N meningitidis or Neisseria gonorrhoea.
* Major known congenital malformation or serious chronic disorder.
* Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorder such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder.

Does not include resolving syndromes due to birth trauma such as Erb palsy.

* Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies).
* Received any investigational drugs, vaccines or devices (aside from those specified in the protocol) within 4 weeks before administration of the first dose of test article or at any time throughout the study.
* Participation in purely observational studies is acceptable.
* Infant who is a direct descendant (child, grandchild) of the study site personnel.

Primary outcomes:
measure: Percentage of Participants Achieving at Least 1:4 rLP2086-specific Serum Bactericidal Assay (SBA) Titer to 1 Subfamily A Strain and 1 Subfamily B Strain
timeFrame: 1 month after Dose 3
measure: Percentage of Participants With at Least One Adverse Event (AE)
timeFrame: From signing of informed consent form to completion of study (up to 2 years)
Secondary outcomes:
measure: Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs) for 1 Subfamily A Strain and 1 Subfamily B Strain
timeFrame: 1 month after Dose 2, Dose 3; before Dose 4
measure: Percentage of Participants Achieving at Least 1:4, 1:8, 1:16, 1:32, 1:64, 1:128 rLP2086-specific SBA Titer to 1 Subfamily A Strain and 1 Subfamily B Strain
timeFrame: 1 month after Dose 2, Dose 3; before Dose 4
Other outcomes:
measure: Percentage of Participants Achieving Response >=1:4 for Additional Meningococcal Serogroup B (MnB) Test Strain-specific SBA Titer
timeFrame: 1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4
measure: Percentage of Participants Achieving SBA Titer Levels >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Additional MnB Test Strains
timeFrame: 1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4
measure: Serum Bactericidal Assay (SBA) GMTs for Additional MnB Test Strains
timeFrame: 1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4
Locations:
city: Santiado de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
state: La Coruña
city: Mostóles
country: Spain
facility: Hospital Universitario de Mostóles
state: Madrid
city: Pamplona
country: Spain
facility: Hospital Virgen del Camino
state: Navarra
city: Almeria
country: Spain
facility: Clínica Mediterráneo
city: Madrid
country: Spain
facility: Hospital Gral. Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital 12 de Octubre Materno-Infantil Unidad de Lactantes
city: Vigo
country: Spain
facility: Hospital Xeral de Vigo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Martinon-Torres F, Gimenez-Sanchez F, Bernaola-Iturbe E, Diez-Domingo J, Jiang Q, Perez JL. A randomized, phase 1/2 trial of the safety, tolerability, and immunogenicity of bivalent rLP2086 meningococcal B vaccine in healthy infants. Vaccine. 2014 Sep 8;32(40):5206-11. doi: 10.1016/j.vaccine.2014.07.049. Epub 2014 Jul 29.