Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants

Meningitis, Meningococcal Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00798304
• Other study ID #: 6108K2-2000
• Secondary ID: B19710082008-001
• Status: Terminated
• Phase: Phase 2
• First received: November 25, 2008
• Last updated: November 21, 2014
• Start date: January 2009
• Est. completion date: September 2009

Study information

• Verified date: November 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: September 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 42 Days to 98 Days

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningitis, Meningococcal

Intervention

Biological:
• meningococcal B rLP2086 vaccine
vaccination
• Routine age appropriate childhood vaccines
vaccination
• meningococcal B rLP2086 vaccine
vaccination
• Routine age appropriate childhood vaccines
vaccination
• Routine age appropriate childhood vaccines
vaccination

Locations

Country	Name	City	State
Spain	Clínica Mediterráneo	Almeria
Spain	Hospital 12 de Octubre Materno-Infantil Unidad de Lactantes	Madrid
Spain	Hospital Gral. Gregorio Maranon	Madrid
Spain	Hospital Universitario de Mostóles	Mostóles	Madrid
Spain	Hospital Virgen del Camino	Pamplona	Navarra
Spain	Hospital Clinico Universitario de Santiago	Santiado de Compostela	La Coruña
Spain	Hospital Xeral de Vigo	Vigo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants Achieving Response >=1:4 for Additional Meningococcal Serogroup B (MnB) Test Strain-specific SBA Titer		1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4	No
Other	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		1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4	No
Other	Serum Bactericidal Assay (SBA) GMTs for Additional MnB Test Strains		1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4	No
Primary	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		1 month after Dose 3	No
Primary	Percentage of Participants With at Least One Adverse Event (AE)		From signing of informed consent form to completion of study (up to 2 years)	No
Secondary	Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs) for 1 Subfamily A Strain and 1 Subfamily B Strain		1 month after Dose 2, Dose 3; before Dose 4	No
Secondary	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		1 month after Dose 2, Dose 3; before Dose 4	No

External Links

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