Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants
This study has been terminated.
(Following program review within Pfizer, decision was made not to go ahead with this study. This study is cancelled)
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00798304
First received: November 25, 2008
Last updated: February 20, 2013
Last verified: February 2013
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Purpose
The primary purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B vaccine in healthy infants.
| Condition | Intervention | Phase |
|---|---|---|
|
Meningitis, Meningococcal |
Biological: meningococcal B rLP2086 vaccine Biological: Routine age appropriate childhood vaccines |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Open Label, Randomized, Phase 1/2 Trial Of The Safety, Tolerability, And Immunogenicity Of Meningococcal Group B Rlp2086 Vaccine In Healthy Infants |
Resource links provided by NLM:
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Primary Outcome Measures:
- The primary immunological endpoint is the response rate of rLP2086 specific SBA titers to 1 subfamily A strain and 1 subfamily B strain in serum obtained 1 month after dose 3 in subjects receiving dose levels. [ Time Frame: Approximately 7 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- SBA titers (measured as geometric mean titers (GMT)) for 1 subfamily A strain and 1 subfamily B strain at each blood sampling time point during stage 1 [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
- Proportion of subjects achieving an rLP2086-specific SBA titer ≥1:4, ≥1:8, ≥1:16, ≥1:32,≥1:64, ≥1:128 for 1 subfamily A strain and 1 subfamily B strain, at each blood sampling time point during [ Time Frame: pproximately 12 months ] [ Designated as safety issue: No ]
- stage 1; [ Time Frame: pproximately 12 months ] [ Designated as safety issue: No ]
- SBA titers (measured as response rates, proportion of subjects achieving different titer levels, and GMTs) may be assessed for additional MnB test strains at each blood sampling time point during the study (stage 1 and stage 2). [ Time Frame: pproximately 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 46 |
| Study Start Date: | January 2009 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Dose level 1 of meningococcal B rLP2086 vaccine and routine childhood vaccines
|
Biological: meningococcal B rLP2086 vaccine
vaccination
Biological: Routine age appropriate childhood vaccines
vaccination
|
|
Experimental: 2
Dose level 2 of meningococcal B rLP2086 vaccine and routine childhood vaccines
|
Biological: meningococcal B rLP2086 vaccine
vaccination
Biological: Routine age appropriate childhood vaccines
vaccination
|
|
Experimental: 3
Control group
|
Biological: Routine age appropriate childhood vaccines
vaccination
|
Eligibility| Ages Eligible for Study: | 42 Days to 98 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Wyeth is now a wholly owned subsidiary of Pfizer |
| ClinicalTrials.gov Identifier: | NCT00798304 History of Changes |
| Other Study ID Numbers: | 6108K2-2000, B1971008 |
| Study First Received: | November 25, 2008 |
| Last Updated: | February 20, 2013 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
|
Meningococcal B vaccine infants safety immunogenicity |
Additional relevant MeSH terms:
|
Meningitis Meningitis, Meningococcal Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Meningitis, Bacterial |
Central Nervous System Bacterial Infections Bacterial Infections Meningococcal Infections Neisseriaceae Infections Gram-Negative Bacterial Infections |
ClinicalTrials.gov processed this record on May 19, 2013