A Trial to Assess the Safety, Tolerability and Immunogenicity of Repevax and rLP2086 Vaccine When Given Together in Healthy Subjects Aged >=11 to <19 Years.
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01323270
Collaborator
(none)
753
36
2
23.1
20.9
0.9
Study Details
Study Description
Brief Summary
This study is to look at a new vaccine that might prevent meningococcal disease, and to look at the safety of the new vaccine as well as how it is tolerated when given together with Repevax. The study will be done in healthy adolescents.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
753 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
A Phase 2, Randomized, Placebo-controlled, Single-blind Trial To Assess The Safety, Tolerability, And Immunogenicity Of Repevax(Registered) And Bivalent Rlp2086 Vaccine When Administered Concomitantly In Healthy Subjects Aged >/= 11 To <19 Years
Study Start Date
:
Mar 1, 2011
Actual Primary Completion Date
:
Oct 1, 2012
Actual Study Completion Date
:
Feb 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: rLP2086 rLP2086 and Repevax |
Biological: rLP2086
0.5 mL dose, given at 0, 2 and 6 months.
Biological: Repevax
0.5 mL dose, given at 0 months.
|
| Placebo Comparator: Saline and Repevax Saline and Repevax |
Biological: Saline
0.5 mL dose, given at 0, 2 and 6 months.
Biological: Repevax
0.5 mL dose, given at 0 months.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen [1 month after Vaccination 1]
- Percentage of Participants With at Least One Adverse Event (AE) [Vaccination 1 up to 1 month after Vaccination 3]
Secondary Outcome Measures
- Geometric Mean Concentration (GMC) for Diphtheria and Tetanus Antigens [1 month after Vaccination 1]
- GMC for Acellular Pertussis Antigens [1 month after Vaccination 1]
Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL)
- Geometric Mean Titer (GMT) for Poliomyelitis Antigens [1 month after Vaccination 1]
- Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal to (>=) Prespecified Titer Level [1 month after Vaccination 3]
Other Outcome Measures
- Immunoglobulin G (IgG) Measured by Geometric Mean Titer (GMT) [Before vaccination 1, 1 month after Vaccination 2, 3]
- Geometric Mean Fold-Rise (GMFR) for IgG [Before Vaccination 1, 1 month after Vaccination 2, 3]
Eligibility Criteria
Criteria
Ages Eligible for Study:
11 Years
to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Evidence of a personally signed and dated informed consent document indicating that the parent/legally acceptable representative and/or subject has been informed of all pertinent aspects of the study.
-
Parent/legally acceptable representative and/or subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
-
Male or female subject aged ≥11 and <19 years at the time of enrollment.
-
Available for the entire study period and can be reached by telephone.
-
Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
-
Has received full series of diphtheria, tetanus, and pertussis (DTP)/DTaP vaccines and oral poliomyelitis virus (OPV)/IPV vaccines per country-specific recommendations applicable at the time of receipt.
-
All male and female subjects must agree to practice a form of effective contraception, such as barrier contraception (ie, condom plus spermicide, a female condom, diaphragm, cervical cap or intrauterine device), implants, injectables, combined oral contraceptives or sexual abstinence prior to entering into the study, for the duration of the vaccination period and for 28 days after the last study vaccination. For Germany: The phrase sexual abstinence is not applicable, with the understanding that all male and all female subjects of childbearing potential must practice an effective form of contraception during the study.
-
Negative urine pregnancy test for female subjects.
Exclusion Criteria:
-
Previous vaccination with any meningococcal serogroup B vaccine.
-
Vaccination with any diphtheria, tetanus, pertussis, or poliomyelitis virus vaccine within 5 years of the first study vaccination.
-
A previous anaphylactic reaction to any vaccine or vaccine-related component.
-
Contraindication to vaccination with diphtheria, tetanus, pertussis, or poliomyelitis virus vaccine.
-
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
-
A known or suspected disease of the immune system or those receiving immunosuppressive therapy.
-
History of culture-proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae.
-
Significant neurological disorder or history of seizure (excluding simple febrile seizure).
-
Receipt of any blood products, including immunoglobulin within 6 months before the first study vaccination.
-
Current chronic use of systemic antibiotics.
-
Participation in other studies during study participation. Participation in purely observational studies is acceptable.
-
Received any investigational drugs, vaccines or devices within 28 days before administration of the first study vaccination.
-
Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
-
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
-
Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
-
Subject is a direct descendant (eg, child, grandchild or other family member) of study site or Pfizer personnel.
-
Subject is pregnant or breastfeeding.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Espoo Vaccine Research Clinic | Espoo | Finland | 02100 | |
| 2 | Helsinki South Vaccine Research Clinic | Helsinki | Finland | 00100 | |
| 3 | Ita-Helsinki Vaccine Research Clinic | Helsinki | Finland | 00930 | |
| 4 | Järvenpää Vaccine Research Clinic | Järvenpää | Finland | 04400 | |
| 5 | Kokkola Vaccine Research Clinic | Kokkola | Finland | 67100 | |
| 6 | Lahti Vaccine Research Clinic | Lahti | Finland | 15140 | |
| 7 | Oulu Vaccine Research Clinic | Oulu | Finland | 90220 | |
| 8 | Pori Vaccine Research Clinic | Pori | Finland | 28100 | |
| 9 | Seinäjoki Vaccine Research Clinic | Seinäjoki | Finland | 60100 | |
| 10 | Tampereen Yliopisto University Of Tampere | Tampere | Finland | 33014 | |
| 11 | Tampere Vaccine Research Clinic | Tampere | Finland | 33100 | |
| 12 | Vaccine Research Center | Tampere | Finland | FIN-33014 | |
| 13 | Turku Vaccine Research Clinic | Turku | Finland | 20520 | |
| 14 | Vantaa Vaccine Research Clinic | Vantaa | Finland | 01300 | |
| 15 | Gemeinschaftspraxis Dr. med. Guido Hein, Dr. med. Rainer Lauf | Bad Sobernheim | Germany | 55566 | |
| 16 | Gerhard Bleckmann Kinder- und Jugendarzt | Baunatal | Germany | 34225 | |
| 17 | Kinderarzt-Praxis | Bramsche | Germany | 49565 | |
| 18 | Gemeinschaftspraxis fuer Kinder- und Jugendmedizin Dres. Behre, Burgert, Gunkel | Kehl | Germany | 77694 | |
| 19 | Dr. med. Sobhi Mahdi Kinderarzt und Jugendmedizin | Luebeck | Germany | 23566 | |
| 20 | Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Mainz | Germany | 55131 | |
| 21 | Dr. Michael Vomstein, Hermann Oesterle, Kinder- und Jugendaerzte | Schwaebisch-Hall | Germany | 74523 | |
| 22 | Thomas Lenz & (Frau) Dr. med. Marin Eggers | Vellmar | Germany | 34246 | |
| 23 | Dres.T. Schmitz, H. Knee, Ch, Wittermann Fachaerztliche | Weilheim | Germany | 82362 | |
| 24 | Gemeinschaftspraxis fuer Kinder und Jugendliche Welzheim | Welzheim | Germany | 73642 | |
| 25 | Gabinet Lekarski | Debica | Poland | 39-200 | |
| 26 | Krakowski Szpital Specjalistyczny, im. Jana Pawla II | Krakow | Poland | 31-202 | |
| 27 | NZOZ Salmed | Leczna | Poland | 21-010 | |
| 28 | Specjalistyczna Praktyka Lekarska Gravita | Lodz | Poland | 91-347 | |
| 29 | Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Oddzial Pediatryczny | Lubartow | Poland | 21-100 | |
| 30 | NZOZ Praktyka Lekarza Rodzinnego Eskulap | Lublin | Poland | 20-044 | |
| 31 | NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak | Oborniki Slaskie | Poland | 55-120 | |
| 32 | Specjalistyczny ZOZ nad Matka i Dzieckiem, Przychodnia Wieku Rozwojowego | Poznan | Poland | 61-825 | |
| 33 | NZLA Michalkowice Jarosz i Partnerzy | Siemianowice Slaskie | Poland | 41-103 | |
| 34 | NZOZ Nasz Lekarz | Torun | Poland | 87-100 | |
| 35 | Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny | Trzebnica | Poland | 55-100 | |
| 36 | Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu | Wroclaw | Poland | 50-345 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01323270
Other Study ID Numbers:
- B1971010
- 6108A1-2008
- 2010-022449-38
First Posted:
Mar 25, 2011
Last Update Posted:
May 15, 2015
Last Verified:
Apr 1, 2015
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | A total of 753 participants were enrolled in this study. Of these, 4 participants were not randomized but were vaccinated rLP2086 vaccine or Repevax or Saline at Vaccination 1. These participants were included in safety population and not intent-to-treat population. |
| Arm/Group Title | Group 1: rLP2086 + Repevax | Group 2: Saline+Repevax |
|---|---|---|
| Arm/Group Description | Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month. | Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month. |
| Period Title: Overall Study | ||
| STARTED | 373 | 376 |
| COMPLETED | 330 | 347 |
| NOT COMPLETED | 43 | 29 |
Baseline Characteristics
| Arm/Group Title | Group 1: rLP2086 + Repevax | Group 2: Saline+Repevax | Total |
|---|---|---|---|
| Arm/Group Description | Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month. | Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month. | Total of all reporting groups |
| Overall Participants | 373 | 376 | 749 |
| Age, Customized (participants) [Number] | |||
| Greater than or equal (>=)11-less than (<)14years |
217
58.2%
|
215
57.2%
|
432
57.7%
|
| >=14 years-<19 years |
156
41.8%
|
161
42.8%
|
317
42.3%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
183
49.1%
|
184
48.9%
|
367
49%
|
| Male |
190
50.9%
|
192
51.1%
|
382
51%
|
Outcome Measures
| Title | Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen |
|---|---|
| Description | |
| Time Frame | 1 month after Vaccination 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Group 1: rLP2086 + Repevax | Group 2: Saline+Repevax |
|---|---|---|
| Arm/Group Description | Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month. | Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month. |
| Measure Participants | 337 | 348 |
| Diphtheria |
99.4
26.6%
|
99.4
26.4%
|
| Tetanus |
100.0
26.8%
|
100.0
26.6%
|
| Pertussis toxoid |
94.7
25.4%
|
96.0
25.5%
|
| Pertussis filamentous hemagglutinin |
100.0
26.8%
|
100.0
26.6%
|
| Pertussis pertactin |
100.0
26.8%
|
100.0
26.6%
|
| Pertussis fimbrial agglutinogens types 2+3 |
97.6
26.2%
|
98.9
26.3%
|
| Poliovirus type 1 |
100.0
26.8%
|
100.0
26.6%
|
| Poliovirus type 2 |
100.0
26.8%
|
100.0
26.6%
|
| Poliovirus type 3 |
100.0
26.8%
|
100.0
26.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 1: rLP2086 + Repevax, Group 2: Saline+Repevax |
|---|---|---|
| Comments | Diphtheria: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority criteria margin was 10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percent difference |
| Estimated Value | -0.0 | |
| Confidence Interval |
(2-Sided) 95% -1.6 to 1.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Group 1: rLP2086 + Repevax, Group 2: Saline+Repevax |
|---|---|---|
| Comments | Tetanus: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority criteria margin was 10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percent difference |
| Estimated Value | 0.0 | |
| Confidence Interval |
(2-Sided) 95% -1.1 to 1.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Group 1: rLP2086 + Repevax, Group 2: Saline+Repevax |
|---|---|---|
| Comments | Pertussis toxoid: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority criteria margin was 10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percent difference |
| Estimated Value | -1.3 | |
| Confidence Interval |
(2-Sided) 95% -4.7 to 1.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Group 1: rLP2086 + Repevax, Group 2: Saline+Repevax |
|---|---|---|
| Comments | Pertussis filamentous hemagglutinin: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority criteria margin was 10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percent difference |
| Estimated Value | 0.0 | |
| Confidence Interval |
(2-Sided) 95% -1.1 to 1.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Group 1: rLP2086 + Repevax, Group 2: Saline+Repevax |
|---|---|---|
| Comments | Pertussis pertactin: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority criteria margin was 10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percent difference |
| Estimated Value | 0.0 | |
| Confidence Interval |
(2-Sided) 95% -1.1 to 1.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Group 1: rLP2086 + Repevax, Group 2: Saline+Repevax |
|---|---|---|
| Comments | Pertussis fimbrial agglutinogens types 2+3: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority criteria margin was 10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percent difference |
| Estimated Value | -1.2 | |
| Confidence Interval |
(2-Sided) 95% -3.6 to 0.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Group 1: rLP2086 + Repevax, Group 2: Saline+Repevax |
|---|---|---|
| Comments | Poliovirus type 1: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority criteria margin was 10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percent difference |
| Estimated Value | 0.0 | |
| Confidence Interval |
(2-Sided) 95% -1.1 to 1.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Group 1: rLP2086 + Repevax, Group 2: Saline+Repevax |
|---|---|---|
| Comments | Poliovirus type 2: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority criteria margin was 10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percent difference |
| Estimated Value | 0.0 | |
| Confidence Interval |
(2-Sided) 95% -1.1 to 1.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Group 1: rLP2086 + Repevax, Group 2: Saline+Repevax |
|---|---|---|
| Comments | Poliovirus type 3: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority criteria margin was 10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percent difference |
| Estimated Value | 0.0 | |
| Confidence Interval |
(2-Sided) 95% -1.1 to 1.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Geometric Mean Concentration (GMC) for Diphtheria and Tetanus Antigens |
|---|---|
| Description | |
| Time Frame | 1 month after Vaccination 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Group 1: rLP2086 + Repevax | Group 2: Saline+Repevax |
|---|---|---|
| Arm/Group Description | Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month. | Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month. |
| Measure Participants | 337 | 348 |
| Diphtheria |
1.4
|
1.5
|
| Tetanus |
12.3
|
12.4
|
| Title | GMC for Acellular Pertussis Antigens |
|---|---|
| Description | Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL) |
| Time Frame | 1 month after Vaccination 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Group 1: rLP2086 + Repevax | Group 2: Saline+Repevax |
|---|---|---|
| Arm/Group Description | Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month. | Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month. |
| Measure Participants | 337 | 348 |
| Pertussis toxoid |
27.1
|
26.5
|
| Pertussis filamentous hemagglutinin |
119.4
|
122.9
|
| Pertussis pertactin |
317.0
|
336.1
|
| Pertussis fimbrial agglutinogens types 2+3 |
339.1
|
364.5
|
| Title | Geometric Mean Titer (GMT) for Poliomyelitis Antigens |
|---|---|
| Description | |
| Time Frame | 1 month after Vaccination 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Group 1: rLP2086 + Repevax | Group 2: Saline+Repevax |
|---|---|---|
| Arm/Group Description | Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month. | Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month |
| Measure Participants | 337 | 348 |
| Poliovirus type 1 |
662.1
|
672.6
|
| Poliovirus type 2 |
840.5
|
995.8
|
| Poliovirus type 3 |
2237.4
|
2450.1
|
| Title | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal to (>=) Prespecified Titer Level |
|---|---|
| Description | |
| Time Frame | 1 month after Vaccination 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Group 1: rLP2086 + Repevax | Group 2: Saline+Repevax |
|---|---|---|
| Arm/Group Description | Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month. | Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month. |
| Measure Participants | 307 | 330 |
| PMB80 [A22] 1:16 (N=158, 166) |
95.6
25.6%
|
19.9
5.3%
|
| PMB2001 [A56] 1:8 (N=148, 152) |
100.0
26.8%
|
26.3
7%
|
| PMB2948 [B24] 1:8 (N=157, 170) |
96.8
26%
|
12.9
3.4%
|
| PMB2707 [B44] 1:8 (N=146, 159) |
81.5
21.8%
|
8.2
2.2%
|
| Title | Immunoglobulin G (IgG) Measured by Geometric Mean Titer (GMT) |
|---|---|
| Description | |
| Time Frame | Before vaccination 1, 1 month after Vaccination 2, 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A decision was made, a priori, that the hSBA MnB immunogenicity assay will be used instead of the IgG assay originally planned . Therefore only hSBA assay results will be disclosed. |
| Arm/Group Title | Group 1: rLP2086 + Repevax | Group 2: Saline+Repevax |
|---|---|---|
| Arm/Group Description | Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month. | Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month. |
| Measure Participants | 0 | 0 |
| Title | Geometric Mean Fold-Rise (GMFR) for IgG |
|---|---|
| Description | |
| Time Frame | Before Vaccination 1, 1 month after Vaccination 2, 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| A decision was made, a priori, that the hSBA MnB immunogenicity assay will be used instead of the IgG assay originally planned . Therefore only hSBA assay results will be disclosed. |
| Arm/Group Title | Group 1: rLP2086 + Repevax | Group 2: Saline+Repevax |
|---|---|---|
| Arm/Group Description | Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month. | Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month. |
| Measure Participants | 0 | 0 |
| Title | Percentage of Participants With at Least One Adverse Event (AE) |
|---|---|
| Description | |
| Time Frame | Vaccination 1 up to 1 month after Vaccination 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Summary was performed for participants as per vaccine administration. |
| Arm/Group Title | Group 1: rLP2086 + Repevax | Group 2: Saline+Repevax |
|---|---|---|
| Arm/Group Description | Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month. | Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month. |
| Measure Participants | 374 | 378 |
| Number [percentage of participants] |
37.4
10%
|
40.2
10.7%
|
Adverse Events
| Time Frame | AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Events collected on case report form were reported. Summary was performed for participants as per vaccine administration. | |||
| Arm/Group Title | Group 1: rLP2086 + Repevax | Group 2: Saline+Repevax | ||
| Arm/Group Description | Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month. | Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month. | ||
All Cause Mortality |
||||
| Group 1: rLP2086 + Repevax | Group 2: Saline+Repevax | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Group 1: rLP2086 + Repevax | Group 2: Saline+Repevax | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 12/374 (3.2%) | 9/378 (2.4%) | ||
| Blood and lymphatic system disorders | ||||
| Idiopathic thrombocytopenic purpura | 1/374 (0.3%) | 0/378 (0%) | ||
| Congenital, familial and genetic disorders | ||||
| Syndactyly | 0/374 (0%) | 1/378 (0.3%) | ||
| Ear and labyrinth disorders | ||||
| Vertigo positional | 1/374 (0.3%) | 0/378 (0%) | ||
| Infections and infestations | ||||
| Appendicitis | 1/374 (0.3%) | 2/378 (0.5%) | ||
| Abdominal abscess | 1/374 (0.3%) | 0/378 (0%) | ||
| Appendicitis perforated | 1/374 (0.3%) | 0/378 (0%) | ||
| Arthritis infective | 1/374 (0.3%) | 0/378 (0%) | ||
| Cellulitis | 1/374 (0.3%) | 0/378 (0%) | ||
| Gastroenteritis | 1/374 (0.3%) | 0/378 (0%) | ||
| Peritonsillar abscess | 0/374 (0%) | 1/378 (0.3%) | ||
| Sinusitis | 1/374 (0.3%) | 0/378 (0%) | ||
| Tonsillitis | 1/374 (0.3%) | 0/378 (0%) | ||
| Urinary tract infection | 0/374 (0%) | 1/378 (0.3%) | ||
| Injury, poisoning and procedural complications | ||||
| Hip fracture | 0/374 (0%) | 1/378 (0.3%) | ||
| Injury | 0/374 (0%) | 1/378 (0.3%) | ||
| Joint dislocation | 0/374 (0%) | 1/378 (0.3%) | ||
| Road traffic accident | 1/374 (0.3%) | 0/378 (0%) | ||
| Nervous system disorders | ||||
| Headache | 1/374 (0.3%) | 0/378 (0%) | ||
| Hydrocephalus | 1/374 (0.3%) | 0/378 (0%) | ||
| Syncope | 0/374 (0%) | 1/378 (0.3%) | ||
| Psychiatric disorders | ||||
| Depression | 1/374 (0.3%) | 1/378 (0.3%) | ||
| Drug abuse | 0/374 (0%) | 1/378 (0.3%) | ||
| Reproductive system and breast disorders | ||||
| Ovarian cyst ruptured | 0/374 (0%) | 1/378 (0.3%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnoea | 0/374 (0%) | 1/378 (0.3%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Group 1: rLP2086 + Repevax | Group 2: Saline+Repevax | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 98/374 (26.2%) | 118/378 (31.2%) | ||
| Eye disorders | ||||
| Conjunctivitis | 4/374 (1.1%) | 3/378 (0.8%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 4/374 (1.1%) | 3/378 (0.8%) | ||
| Nausea | 1/374 (0.3%) | 4/378 (1.1%) | ||
| General disorders | ||||
| Pyrexia | 5/374 (1.3%) | 4/378 (1.1%) | ||
| Injection site pain | 4/374 (1.1%) | 0/378 (0%) | ||
| Injection site swelling | 4/374 (1.1%) | 0/378 (0%) | ||
| Infections and infestations | ||||
| Nasopharyngitis | 30/374 (8%) | 31/378 (8.2%) | ||
| Pharyngitis | 17/374 (4.5%) | 19/378 (5%) | ||
| Upper respiratory tract infection | 16/374 (4.3%) | 19/378 (5%) | ||
| Bronchitis | 9/374 (2.4%) | 18/378 (4.8%) | ||
| Gastroenteritis | 8/374 (2.1%) | 11/378 (2.9%) | ||
| Sinusitis | 8/374 (2.1%) | 6/378 (1.6%) | ||
| Otitis media | 3/374 (0.8%) | 7/378 (1.9%) | ||
| Acute tonsillitis | 1/374 (0.3%) | 7/378 (1.9%) | ||
| Tonsillitis | 1/374 (0.3%) | 7/378 (1.9%) | ||
| Rhinitis | 2/374 (0.5%) | 4/378 (1.1%) | ||
| Injury, poisoning and procedural complications | ||||
| Contusion | 4/374 (1.1%) | 3/378 (0.8%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 6/374 (1.6%) | 7/378 (1.9%) | ||
| Nervous system disorders | ||||
| Headache | 9/374 (2.4%) | 9/378 (2.4%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 2/374 (0.5%) | 6/378 (1.6%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01323270
Other Study ID Numbers:
- B1971010
- 6108A1-2008
- 2010-022449-38
First Posted:
Mar 25, 2011
Last Update Posted:
May 15, 2015
Last Verified:
Apr 1, 2015