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

NCT00798304 | Terminated Phase 2 Results DMC

• 3 other identifiers: 6108K2-2000B19710082008-001457-18
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Meningitis, Meningococcal

Keywords

Meningococcal B vaccine; infants; safety; immunogenicity

Outcome Measures

Primary Outcomes (2)

• 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

• Percentage of Participants With at Least One Adverse Event (AE)

  From signing of informed consent form to completion of study (up to 2 years)

Secondary Outcomes (2)

• 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

• 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

Other Outcomes (3)

• 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

• 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

• 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

Study Arms (3)

1

EXPERIMENTAL

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

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

2

EXPERIMENTAL

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

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

3

EXPERIMENTAL

Control group

Biological: Routine age appropriate childhood vaccines

Interventions

meningococcal B rLP2086 vaccine BIOLOGICAL

vaccination

1

Routine age appropriate childhood vaccines BIOLOGICAL

vaccination

1

Eligibility Criteria

• Age: 42 Days - 98 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (7)

Clínica Mediterráneo

Almería, Almeria, 4007, Spain

Location

Hospital Clinico Universitario de Santiago

Santiado de Compostela, La Coruña, 15706, Spain

Location

Hospital Gral. Gregorio Maranon

Madrid, Madrid, 28007, Spain

Location

Hospital 12 de Octubre Materno-Infantil Unidad de Lactantes

Madrid, Madrid, 28041, Spain

Location

Hospital Universitario de Mostóles

Mostóles, Madrid, 28935, Spain

Location

Hospital Virgen del Camino

Pamplona, Navarre, 31008, Spain

Location

Hospital Xeral de Vigo

Vigo, 36024, Spain

Location

Related Publications (1)

• 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.

  PMID: 25077420 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Meningitis, Meningococcal

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Limitations and Caveats

Immunogenicity results were not reported because the study was terminated due to the reactogenicity profile of the vaccine in infants prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2008
• First Posted: November 26, 2008
• Study Start: January 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: September 1, 2009
• Last Updated: November 26, 2014
• Results First Posted: November 26, 2014

Record last verified: 2014-11

Locations

ES (7)