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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Meningitis, Meningococcal

Treatments: Biological: meningococcal B rLP2086 vaccine; Biological: Routine age appropriate childhood vaccines

Study type: Interventional

Funder types: Industry

Identifiers

NCT00798304

6108K2-2000

B1971008 (Other Identifier)

2008-001457-18 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 46 patients

Sex: All

Ages: 42 to 98 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 3 patient groups

1

Experimental group

Description:

Dose level 1 of meningococcal B rLP2086 vaccine and routine childhood vaccines

Treatment:

Biological: meningococcal B rLP2086 vaccine

Biological: meningococcal B rLP2086 vaccine

Biological: Routine age appropriate childhood vaccines

Biological: Routine age appropriate childhood vaccines

Biological: Routine age appropriate childhood vaccines

2

Experimental group

Description:

Dose level 2 of meningococcal B rLP2086 vaccine and routine childhood vaccines

Treatment:

Biological: meningococcal B rLP2086 vaccine

Biological: meningococcal B rLP2086 vaccine

Biological: Routine age appropriate childhood vaccines

Biological: Routine age appropriate childhood vaccines

Biological: Routine age appropriate childhood vaccines

3

Experimental group

Description:

Control group

Treatment:

Biological: Routine age appropriate childhood vaccines

Biological: Routine age appropriate childhood vaccines

Biological: Routine age appropriate childhood vaccines