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Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

An Open Label, Randomized, Phase 1/2 Trial Of The Safety, Tolerability, And Immunogenicity Of Meningococcal Group B Rlp2086 Vaccine In Healthy Infants

NCT00798304•Pfizer

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

0 - 0 years

Sex

ALL

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.
+4 more criteria

Locations (7)

Clínica Mediterráneo

Almería, Almeria, Spain

Hospital Clinico Universitario de Santiago

Santiado de Compostela, La Coruña, Spain

Hospital Gral. Gregorio Maranon

Madrid, Madrid, Spain

Hospital 12 de Octubre Materno-Infantil Unidad de Lactantes

Madrid, Madrid, Spain

Hospital Universitario de Mostóles

Mostóles, Madrid, Spain

Hospital Virgen del Camino

Pamplona, Navarre, Spain

Hospital Xeral de Vigo

Vigo, Spain

Key Dates

Start Date

January 1, 2009

Primary Completion Date

June 1, 2009

Completion Date

September 1, 2009

Last Updated

November 26, 2014

Enrollment

ACTUAL participants

Conditions

Meningitis, Meningococcal

Interventions

meningococcal B rLP2086 vaccine

BIOLOGICAL

Routine age appropriate childhood vaccines

BIOLOGICAL

meningococcal B rLP2086 vaccine

BIOLOGICAL

Routine age appropriate childhood vaccines

BIOLOGICAL

Routine age appropriate childhood vaccines

BIOLOGICAL

Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Volunteers Aged From 3 to 5 Months

NCT05252715

Meningitis, Meningococcal

View study

TERMINATEDNA

A Study Assessing Colonisation & Immunogenicity After Nasal Inoculation With N. Lactamica and Eradication on Day 4 or 14

NCT03549325

Meningitis, Meningococcal

View study

COMPLETEDPHASE4

A Sourcing Study to Collect Human Blood Samples From Healthy Adults

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 26, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Volunteers Aged From 3 to 5 Months

A Study Assessing Colonisation & Immunogenicity After Nasal Inoculation With N. Lactamica and Eradication on Day 4 or 14

A Sourcing Study to Collect Human Blood Samples From Healthy Adults

RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)

Study of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants