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

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ClinicalTrials.gov Identifier: NCT00798304
Recruitment Status : Terminated (Following program review within Pfizer, decision was made not to go ahead with this study. This study is cancelled)
First Posted : November 26, 2008
Results First Posted : November 26, 2014
Last Update Posted : November 26, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Meningitis, Meningococcal
Interventions Biological: meningococcal B rLP2086 vaccine
Biological: Routine age appropriate childhood vaccines
Enrollment 46
Recruitment Details In this study, participants were to receive recombinant lipoprotein 2086 (rLP2086) vaccine at 2, 4, 6 and 12 months of age. Due to premature termination of study, only single dose of 20 or 60 microgram (mcg) of rLP2086 vaccine was administered at 2 months and planned treatments of rLP2086 vaccine 120 mcg and 200 mcg were not administered.
Pre-assignment Details  
Arm/Group Title Control rLP2086 20 mcg rLP2086 60 mcg
Hide Arm/Group Description Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice. Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice. rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
Period Title: Overall Study
Started 14 22 10
Completed 0 0 0
Not Completed 14 22 10
Reason Not Completed
Adverse Event             0             1             1
Discontinuation by Sponsor             14             21             9
Arm/Group Title Control rLP2086 20 mcg rLP2086 60 mcg Total
Hide Arm/Group Description Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice. Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice. rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice. Total of all reporting groups
Overall Number of Baseline Participants 14 22 10 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 14 participants 22 participants 10 participants 46 participants
63.6  (11.57) 64.0  (10.02) 71.6  (11.35) 65.5  (11.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 22 participants 10 participants 46 participants
Female
6
  42.9%
12
  54.5%
4
  40.0%
22
  47.8%
Male
8
  57.1%
10
  45.5%
6
  60.0%
24
  52.2%
1.Primary Outcome
Title 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
Hide Description [Not Specified]
Time Frame 1 month after Dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.
Arm/Group Title Control rLP2086 20 mcg rLP2086 60 mcg
Hide Arm/Group Description:
Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Percentage of Participants With at Least One Adverse Event (AE)
Hide Description [Not Specified]
Time Frame From signing of informed consent form to completion of study (up to 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control rLP2086 20 mcg rLP2086 60 mcg
Hide Arm/Group Description:
Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
Overall Number of Participants Analyzed 14 22 10
Measure Type: Number
Unit of Measure: percentage of participants
21.4 31.8 20.0
3.Secondary Outcome
Title Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs) for 1 Subfamily A Strain and 1 Subfamily B Strain
Hide Description [Not Specified]
Time Frame 1 month after Dose 2, Dose 3; before Dose 4
Hide Outcome Measure Data
Hide Analysis Population Description
Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.
Arm/Group Title Control rLP2086 20 mcg rLP2086 60 mcg
Hide Arm/Group Description:
Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame 1 month after Dose 2, Dose 3; before Dose 4
Hide Outcome Measure Data
Hide Analysis Population Description
Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.
Arm/Group Title Control rLP2086 20 mcg rLP2086 60 mcg
Hide Arm/Group Description:
Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Other Pre-specified Outcome
Title Percentage of Participants Achieving Response >=1:4 for Additional Meningococcal Serogroup B (MnB) Test Strain-specific SBA Titer
Hide Description [Not Specified]
Time Frame 1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4
Hide Outcome Measure Data
Hide Analysis Population Description
Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.
Arm/Group Title Control rLP2086 20 mcg rLP2086 60 mcg
Hide Arm/Group Description:
Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Other Pre-specified Outcome
Title 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
Hide Description [Not Specified]
Time Frame 1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4
Hide Outcome Measure Data
Hide Analysis Population Description
Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.
Arm/Group Title Control rLP2086 20 mcg rLP2086 60 mcg
Hide Arm/Group Description:
Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Other Pre-specified Outcome
Title Serum Bactericidal Assay (SBA) GMTs for Additional MnB Test Strains
Hide Description [Not Specified]
Time Frame 1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4
Hide Outcome Measure Data
Hide Analysis Population Description
Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.
Arm/Group Title Control rLP2086 20 mcg rLP2086 60 mcg
Hide Arm/Group Description:
Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control rLP2086 20 mcg rLP2086 60 mcg
Hide Arm/Group Description Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice. Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice. rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
All-Cause Mortality
Control rLP2086 20 mcg rLP2086 60 mcg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Control rLP2086 20 mcg rLP2086 60 mcg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   4/22 (18.18%)   1/10 (10.00%) 
Infections and infestations       
Bronchitis * 1  0/14 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
Meningitis aseptic * 1  0/14 (0.00%)  0/22 (0.00%)  1/10 (10.00%) 
Urinary tract infection * 1  0/14 (0.00%)  2/22 (9.09%)  0/10 (0.00%) 
Viral infection * 1  0/14 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
Injury, poisoning and procedural complications       
Respiratory syncytial virus bronchiolitis * 1  0/14 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control rLP2086 20 mcg rLP2086 60 mcg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/14 (21.43%)   4/22 (18.18%)   2/10 (20.00%) 
Eye disorders       
Conjunctivitis * 1  1/14 (7.14%)  0/22 (0.00%)  0/10 (0.00%) 
Gastrointestinal disorders       
Gastrooesophageal reflux disease * 1  0/14 (0.00%)  1/22 (4.55%)  1/10 (10.00%) 
Infections and infestations       
Gastroenteritis * 1  0/14 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
Nasopharyngitis * 1  0/14 (0.00%)  0/22 (0.00%)  1/10 (10.00%) 
Respiratory tract infection * 1  1/14 (7.14%)  1/22 (4.55%)  0/10 (0.00%) 
Respiratory tract infection viral * 1  1/14 (7.14%)  0/22 (0.00%)  0/10 (0.00%) 
Viral infection * 1  0/14 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthma * 1  1/14 (7.14%)  0/22 (0.00%)  0/10 (0.00%) 
Skin and subcutaneous tissue disorders       
Dermatitis * 1  1/14 (7.14%)  0/22 (0.00%)  0/10 (0.00%) 
Rash * 1  0/14 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00798304    
Other Study ID Numbers: 6108K2-2000
B1971008 ( Other Identifier: Alias Study Number )
2008-001457-18 ( EudraCT Number )
First Submitted: November 25, 2008
First Posted: November 26, 2008
Results First Submitted: November 21, 2014
Results First Posted: November 26, 2014
Last Update Posted: November 26, 2014