Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-015198-11 | EudraCT Number | ||
| 6108A1-3003 | Other Identifier | Alias Study Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2.
All subjects will be followed for 6 months after the last vaccination to assess safety and tolerability.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rLP2086 vaccine | Experimental | rLP2086 vaccine |
|
| control | Other | The control treatment will be HAVRIX vaccine at month 0 and 6 and a normal saline injection at month 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rLP2086 vaccine | Biological | 120 mcg, 3 doses, at month 0, 2, and 6. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study | An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. | Vaccination 1 up to 6 months after Vaccination 3 |
| Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1 | A medically attended AE was defined as a non-serious AE that required medical attention. | Within 30 days after Vaccination 1 |
| Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2 | A medically attended AE was defined as a non-serious AE that required medical attention. | Within 30 days after Vaccination 2 |
| Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3 | A medically attended AE was defined as a non-serious AE that required medical attention. | Within 30 days after Vaccination 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Here, 'N' signifies those participants who were evaluable for this measure during specified time period. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Accelovance,Inc. | Huntsville | Alabama | 35802 | United States | ||
| Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35164991 | Derived | Beeslaar J, Mather S, Absalon J, Eiden JJ, York LJ, Crowther G, Maansson R, Maguire JD, Peyrani P, Perez JL. Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
A total of 5712 participants in 12 countries were enrolled in this study. Of these, 8 participants were randomized but did not receive study vaccination.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: rLP2086 | Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule |
| FG001 | Group 2: HAV/Saline/HAV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| control |
| Biological |
HAVRIX: 720 EL.U. or 1440 EL.Ul, 2 doses, at month 0 and 6. Placebo: normal saline injection, 1 dose, at month 2. |
|
| Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3) |
| Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods | A medically attended AE was defined as a non-serious AE that required medical attention. | Within 30 days after any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3); throughout study (Vaccination 1 up to 6 months after Vaccination 3) |
| Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods | A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Newly diagnosed chronic medical condition did not include illnesses considered to be temporary conditions. Here, 'N' signifies those participants who were evaluable for this measure during specified time period. | Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase(Vaccination 1 up to 1 month after Vaccination 3); follow-up phase(1 month up to 6 months after Vaccination 3); throughout study(Vaccination 1 up to 6 months after Vaccination 3) |
| Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Here, 'N' signifies those participants who were evaluable for this measure during specified time period. | Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3) |
| Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Any AE that occurred within the first 30 minutes after the administration of study vaccine (bivalent rLP2086, HAV vaccine or saline) was classified as an immediate AE. Here, 'N' signifies those participants who were evaluable for this measure during specified time period. | Within 30 minutes after Vaccination 1, 2, 3 |
| Number of Days Participant Missed School or Work Due to Adverse Events (AEs) | Vaccination 1 up to 1 month after Vaccination 3 |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Clinical Research Advantage, Inc/ East Valley Family Physicians, PLC | Chandler | Arizona | 85224 | United States |
| Cassidy Medical Group/Clinical Research Advantage | Tempe | Arizona | 85282 | United States |
| Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC | Tempe | Arizona | 85282 | United States |
| Clinical Research Advantage, Inc./Prairie Fields Family Medicine, PC Administrative/Mailing Address | Tempe | Arizona | 85282 | United States |
| Harrisburg Family Medical Center | Harrisburg | Arkansas | 72432 | United States |
| Accelovance. Inc | San Diego | California | 92108 | United States |
| Benchmark Research | San Francisco | California | 94102 | United States |
| Cassidy Medical Group/Clinical Research Advantage | Vista | California | 92083 | United States |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Optimal Research, LLC | Melbourne | Florida | 32934 | United States |
| Accelovance | Melbourne | Florida | 32935 | United States |
| Miami Research Associates | South Miami | Florida | 33143 | United States |
| Accelovance,Inc. | Mishawaka | Indiana | 46545 | United States |
| Clinical Research Advantage,Inc/Ridge Family Practice | Council Bluffs | Iowa | 51503 | United States |
| Kentucky Pediatric/Adult Research | Bardstown | Kentucky | 40004 | United States |
| Clinical Research Advantage, Inc./ Pediatric Partners, LLC Additional Site-No IP | Fremont | Nebraska | 68025 | United States |
| Prairie Fields Family Medicine/Clinical Research Advantage | Fremont | Nebraska | 68025 | United States |
| Rochester Clinical Research, Inc. | Rochester | New York | 14609 | United States |
| Rapid Medical Research. Inc. | Cleveland | Ohio | 44122 | United States |
| Ohio Pediatric Research Association | Dayton | Ohio | 45414 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| PMG Research of Bristol | Bristol | Tennessee | 37620 | United States |
| Benchmark Research | Austin | Texas | 78705 | United States |
| Tekton Research | Austin | Texas | 78745 | United States |
| Research Across America | Dallas | Texas | 75234 | United States |
| Benchmark Research | Fort Worth | Texas | 76135 | United States |
| West Houston Clinical Research Service | Houston | Texas | 77055 | United States |
| Research Across America | Katy | Texas | 77450 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| J. Lewis Research, Inc. - Foothill Family Clinic | Salt Lake City | Utah | 84109 | United States |
| J. Lewis Research, Inc. / Foothill Family Clinic South | Salt Lake City | Utah | 84121 | United States |
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
| J. Lewis Research, Inc. - Jordan River Family Medicine | South Jordan | Utah | 84095 | United States |
| Advanced Clinical Research | West Jordan | Utah | 84088 | United States |
| PI-Coor Clinical Research, LLC | Burke | Virginia | 22015 | United States |
| Pediatric Research of Charlottesville | Charlottesville | Virginia | 22902 | United States |
| Australian Clinical Research Network | Maroubra | New South Wales | 2035 | Australia |
| The Children's Hospital at Westmead | Westmead | New South Wales | 2145 | Australia |
| AusTrials Pty Ltd | Sherwood | Queensland | 4075 | Australia |
| Vaccinology and Immunology Research Trials Unit (VIRTU), Discipline of Paediatrics | North Adelaide | South Australia | 5006 | Australia |
| Telethon Institute for Child Health Research | Subiaco | 6008 | Australia |
| Centro De Investigacion Clinica Del Sur | Temuco | Araucania | 4781156 | Chile |
| Cesfam Dr. Jose Symon Ojeda | Conchalí | Santiago Metropolitan | 8550442 | Chile |
| Hospital Clinico de la Pontificia Universidad Catolica de Chile/ | Santiago | Santiago Metropolitan | 8330034 | Chile |
| Centro de Estudios de Vacunas, CESFAM Gabriela Mistral | Santiago | Santiago Metropolitan | 886000 | Chile |
| Hospital Luis Calvo Mackenna | Santiago | 7500539 | Chile |
| Ordinace praktickeho lekare pro deti a dorost | Jindřichův Hradec | 377 01 | Czechia |
| Samostatna ordinace praktickeho lekare pro deti a dorost | Jindřichův Hradec | 377 01 | Czechia |
| Samostatna ordinace praktickeho lekare pro deti a dorost | Jindřichův Hradec | 37701 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Pilsen | 30138 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Prague | 120 00 | Czechia |
| Prakticky Lekar Pro Deti a Mladez | Týnec nad Sázavou | 257 41 | Czechia |
| Aarhus Universitetshospital, Skejby | Aarhus N | 8200 | Denmark |
| Eraarst Kersti Veidrik Ou | Rakvere | 44316 | Estonia |
| Innomedica OU | Tallinn | 10117 | Estonia |
| Merekivi Perearstid OU | Tallinn | 10617 | Estonia |
| Merelahe Family Doctors Centre | Tallinn | 10617 | Estonia |
| Pori Vaccine Research Clinic | Pori | 28100 | Finland |
| Tampere Vaccine Research Clinic | Tampere | 33100 | Finland |
| Turku Vaccine Research Clinic | Turku | 20520 | Finland |
| Clinical Trial Center North | Hamburg | 20246 | Germany |
| Clinical Trial Center North GmbH & Co.KG | Hamburg | 20251 | Germany |
| Bernhard Nocht Centre for Clinical Trials (BNCCT) | Hamburg | 20359 | Germany |
| Juliusspital Wuerzburg | Würzburg | 97070 | Germany |
| JSC "InMedica" | Kaunas | 48259 | Lithuania |
| Saules Family Medicine Centre | Kaunas | LT-49449 | Lithuania |
| Kaunas Clinical Hospital, Public Institution, Clinic of Infectious Diseases | Kaunas | LT47116 | Lithuania |
| LITHUANIAN HEALTH SCIENCE UNIVERSITY HOSPITAL, CLINIC of FAMILY MEDICINE | Kaunas | LT50009 | Lithuania |
| Centro poliklinika, Public Institution | Vilnius | LT01117 | Lithuania |
| Krakowski Szpital Specjalistyczny im Jana Pawla II | Krakow | Poland | 31-202 | Poland |
| Prywatny Gabinet Lekarski Dr.n.med.Jerzy Brzostek | Dębica | 39-200 | Poland |
| Hanna Czajka Indywidualna Specjalistyczna Praktyka Lekarska | Krakow | 31-302 | Poland |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny | Lubartów | 21-100 | Poland |
| NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak | Oborniki Śląskie | 55-120 | Poland |
| Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu | Poznan | 61-709 | Poland |
| NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska | Siemianowice Śląskie | 41-103 | Poland |
| NZOZ Nasz Lekarz | Torun | 87-100 | Poland |
| Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny | Trzebnica | 55-100 | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu | Wroclaw | 50-345 | Poland |
| Instituto Hispalense de Pediatria | Seville | Sevilla | 41014 | Spain |
| Clinicas Universitarias. Universidad Catolica de Valencia San Vicente Martir | Valencia | Valencia | 46001 | Spain |
| Vaccinenheten Barn- och ungdomsmedicinska kliniken | Malmö | SE | 205 02 | Sweden |
| Norrlands Universitetssjukhus, Institution för Pediatrik | Umeå | 90185 | Sweden |
Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
| Vaccination 1 |
|
| Vaccination 2 |
|
| Vaccination 3 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population included all participants who were randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: rLP2086 | Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule |
| BG001 | Group 2: HAV/Saline/HAV | Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study | An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. | Safety population included all participants who received at least 1 dose of study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available. | Posted | Number | 95% Confidence Interval | percentage of participants | Vaccination 1 up to 6 months after Vaccination 3 |
|
|
| ||||||||||||||||||||||||||||
| Primary | Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1 | A medically attended AE was defined as a non-serious AE that required medical attention. | Vaccination 1 safety population included all participants who received the first dose of study vaccine (bivalent rLP2086 or HAV vaccine) and had safety information available from Vaccination 1 until prior to Vaccination 2. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 30 days after Vaccination 1 |
|
| |||||||||||||||||||||||||||||
| Primary | Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2 | A medically attended AE was defined as a non-serious AE that required medical attention. | Vaccination 2 safety population included all participants who received the second dose of study vaccine (bivalent rLP2086 or saline) and had safety information available from Vaccination 2 until prior to Vaccination 3. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 30 days after Vaccination 2 |
|
| |||||||||||||||||||||||||||||
| Primary | Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3 | A medically attended AE was defined as a non-serious AE that required medical attention. | Vaccination 3 safety population included all participants who received the third dose of study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available from Vaccination 3 to post Vaccination 3 follow-up visit (1 month after Vaccination 3). | Posted | Number | 95% Confidence Interval | percentage of participants | Within 30 days after Vaccination 3 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Here, 'N' signifies those participants who were evaluable for this measure during specified time period. | Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods | A medically attended AE was defined as a non-serious AE that required medical attention. | Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 30 days after any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3); throughout study (Vaccination 1 up to 6 months after Vaccination 3) |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods | A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Newly diagnosed chronic medical condition did not include illnesses considered to be temporary conditions. Here, 'N' signifies those participants who were evaluable for this measure during specified time period. | Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase(Vaccination 1 up to 1 month after Vaccination 3); follow-up phase(1 month up to 6 months after Vaccination 3); throughout study(Vaccination 1 up to 6 months after Vaccination 3) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Here, 'N' signifies those participants who were evaluable for this measure during specified time period. | Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3) |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Any AE that occurred within the first 30 minutes after the administration of study vaccine (bivalent rLP2086, HAV vaccine or saline) was classified as an immediate AE. Here, 'N' signifies those participants who were evaluable for this measure during specified time period. | Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 30 minutes after Vaccination 1, 2, 3 |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Days Participant Missed School or Work Due to Adverse Events (AEs) | Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available. | Posted | Median | Full Range | days | Vaccination 1 up to 1 month after Vaccination 3 |
|
|
AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: rLP2086 | Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule | 59 | 3,796 | 1,671 | 3,796 | ||
| EG001 | Group 2: HAV/Saline/HAV | Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month | 48 | 1,908 | 640 | 1,908 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Autoimmune thyroiditis | Endocrine disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hyperprolactinaemia | Endocrine disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hypothalamo-pituitary disorder | Endocrine disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Duodenal perforation | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Biliary dyskinesia | Hepatobiliary disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Allergy to arthropod sting | Immune system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Breast abscess | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Carbuncle | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Meningitis enterococcal | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Meningitis enteroviral | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pertussis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pilonidal cyst | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Salpingitis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Tick-borne viral encephalitis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
| |
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
| |
| Gun shot wound | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
| |
| Heat stroke | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
| |
| Snake bite | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Central Nervous System germinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Demyelination | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Meningism | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Radicular syndrome | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA v17.0 | Non-systematic Assessment |
| |
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA v17.0 | Non-systematic Assessment |
| |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA v17.0 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Substance abuse | Psychiatric disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Attention deficit or hyperactivity disorder | Psychiatric disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Schizoaffective disorder | Psychiatric disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Testicular torsion | Reproductive system and breast disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Vaccination site pain | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D008585 | Meningitis, Meningococcal |
| ID | Term |
|---|---|
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D008589 | Meningococcal Infections |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |
Not provided
Not provided
| Male |
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Participants |
|
|
|