Duration of hSBA Response After a Primary Series of Bivalent rLP2086 Followed by a Booster Dose

NCT01543087 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: B19710332011-005697-31
• Study Type: interventional
• Target: 698
• Locations: 6 countries
• Sites: 56

Brief Summary

This study is to assess the longevity of immune response in adolescents for approximately 48 months after receipt of a primary series of bivalent rLP2086 vaccination, which is then followed by a booster dose and an assessment of immune response for 12 or 26 months post booster vaccination.

Conditions

Meningococcal Infection

Outcome Measures

Primary Outcomes (23)

• Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 6 (Visit 1) After Primary Vaccinations

  For immunogenicity assessment, serum bactericidal assay using human complement (hSBA) was performed with 4 primary Neisseria meningitidis serogroup B (MnB) test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 percent (%) confidence interval (CIs). LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Participants who received bivalent rLP2086 in primary study B1971012, entered in this study at Month 12 (Visit 2). Hence, no participants enrolled from primary study B1971012 had serology results at Month 6.

  Month 6 (Visit 1 of study B1971033)

• Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations

  For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).

  Month 12 (Visit 2 of study B1971033)

• Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations

  For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).

  Month 18 (Visit 3 of study B1971033)

• Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations

  For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).

  Month 24 (Visit 4 of study B1971033)

• Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations

  For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).

  Month 36 (Visit 5 of study B1971033)

• Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations

  For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).

  Month 48 (Visit 6 of study B1971033)

• Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study

  For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Participants of Group 3c (participants from primary study B1971015) were not continued in booster stage.

  1 month after last vaccination in primary study

• Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6])

  For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Participants of Group 3c (participants from primary study B1971015) were not continued in booster stage.

  Visit 6 of study B1971033 (48 months after last vaccination in primary study)

• Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8)

  For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Participants of Group 3c (participants from primary study B1971015) were not continued in booster stage.

  Visit 8 (1 month following the booster vaccination on Month 49)

• Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10)

  For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Participants of Group 3c (participants from primary study B1971015) were not continued in booster stage.

  Visit 10 (12 months following the booster vaccination on Month 60)

• Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to(>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 26 Months After the Booster Vaccination(Visit 11)

  For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Participants of Group 3c (participants from primary study B1971015) were not continued in booster stage. only participants who received bivalent rLP2086 in primary study B1971010 were not analysed for this endpoint. Only participants who received bivalent rLP2086 in primary study B1971012 on a 0-, 2-, and 6-month or a 0- and 6-month vaccination schedule were eligible to be followed for 26 months after booster vaccination

  Visit 11 (26 months following the booster vaccination on Month 74)

• Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination

  Local reactions were collected by using an e-diary and included pain at injection site, redness and swelling. Redness and swelling were graded as: none (0-2.0 centimetre \[cm\]), mild (2.5-5.0 cm), moderate (greater than \[\>\] 5.0-10.0 cm) and severe (\>10.0 cm). Pain was graded as: mild (does not interfere with activity), moderate (Interferes with activity) and severe (prevents daily activity).

  Within 7 days after booster vaccination on Month 48

• Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination

  Systemic reactions included: fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at the injection site and joint pain, all other systemic reactions were recorded by using an e-diary. Fever was categorized as: 38.0 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \> 40.0 degree C. Vomiting was graded as: mild (1 to 2 times in 24 hours \[hrs\]), moderate (\>2 times in 24 hrs) and severe (requires intravenous \[IV\] hydration); Diarrhea was graded as: mild (2 to 3 loose stools in 24 hrs), moderate (4 to 5 loose stools in 24 hrs) and severe (6 or more loose stools in 24 hrs); Headache, fatigue, chills, muscle pain and joint pain was graded as: mild (does not interfere with daily activities), moderate (some interference with activity) and severe (prevents daily routine activity).

  Within 7 days after booster vaccination on Month 48

• Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8)

  An AE was any untoward medical occurrence in a participant who received investigational product 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/incapacity; congenital anomaly. AEs included both non-serious AEs and serious adverse events (SAEs). An NDCMC was defined as a disease or medical condition, that was not identified previously and that was expected to be persistent or otherwise long-lasting in its effects. The investigator determined if the AE was an NDCMC. An MAE was defined as a non serious AE (AE other than SAE) that resulted in an evaluation at a medical facility.

  From Visit 7 (Month 48) to Visit 8 (Month 49) in Booster stage

• Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Follow-Up Phase (Visit 8 to Visit 9)

  An AE was any untoward medical occurrence in a participant who received investigational product 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/incapacity; congenital anomaly. An MAE was defined as a non serious AE (AE other than SAE) that resulted in an evaluation at a medical facility.

  Visit 8 (Month 49) to Visit 9 (Month 54) in Booster stage

• Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Vaccination Through 6 Months After Booster Vaccination (Visit 7 to Visit 9)

  An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Serious adverse event (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/incapacity; congenital anomaly. An MAE was defined as a nonserious AE (AE other than SAE) that resulted in an evaluation at a medical facility.

  From Visit 7 (time of booster vaccination, Month 48) to Visit 9 (6 months after booster vaccination, Month 54)

• Percentage of Participants With Newly Diagnosed Chronic Medical Condition;(NDCMC) From the 6-Month Safety Telephone Call in the Primary Study Through 48 Months After the Last Dose in the Primary Study (Visit 6 in Stage 1)

  An NDCMC was defined as a disease or medical condition, that was not identified previously and that was expected to be persistent or otherwise long-lasting in its effects. The investigator determined if the AE was an NDCMC.

  Visit 1 of B1971033 (6-month safety telephone call after last dose in primary study) to Visit 6 of B1971033 (6 months after last primary dose to 48 months after last primary dose in primary study)

• Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Booster Vaccination Through 12 Months After Booster Vaccination (Visit 8 to Visit 10)

  An NDCMC was defined as a disease or medical condition, that was not identified previously and that was expected to be persistent or otherwise long-lasting in its effects. The investigator determined if the AE was an NDCMC.

  From Visit 8 (1 month after booster vaccination, Month 49) to Visit 10 (12 months after booster vaccination, Month 60)

• Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) From Booster Stage Vaccination Through 12 Months After Booster Vaccination (Visit 7 to Visit 10)

  An NDCMC was defined as a disease or medical condition, that was not identified previously and that was expected to be persistent or otherwise long-lasting in its effects. The investigator determined if the AE was an NDCMC.

  From Visit 7 (time of booster vaccination, Month 48) to Visit 10 (12 months after booster vaccination, Month 60)

• Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Booster Vaccination Through 26 Months After Booster Vaccination (Visit 8 to Visit 11)

  An NDCMC was defined as a disease or medical condition, that was not identified previously and that was expected to be persistent or otherwise long-lasting in its effects. The investigator determined if the AE was an NDCMC. Participants who received bivalent rLP2086 in primary study B1971012 on a 0-, 2-, and 6-month or a 0- and 6-month vaccination schedule were eligible to be follow up for 26 months after booster vaccination.

  From Visit 8 (1 month after booster vaccination, Month 49) to Visit 11 (26 months after booster vaccination, Month 74)

• Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From Booster Vaccine Through 26 Months After Booster Vaccination (Visit 7 to Visit 11)

  An NDCMC was defined as a disease or medical condition, that was not identified previously and that was expected to be persistent or otherwise long-lasting in its effects. The investigator determined if the AE was an NDCMC. Participants who received bivalent rLP2086 in primary study B1971012 on a 0-, 2-, and 6-month or a 0- and 6-month vaccination schedule were eligible to be follow up for 26 months after booster vaccination.

  From Visit 7 (time of booster vaccination, Month 48) to Visit 11 (26 months after booster vaccination, Month 74)

• Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Booster Vaccination

  Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.

  Within 30 minutes after Booster Vaccination in Month 48

• Number of Days Participants Missed Work or School Due to AE From Booster Vaccination Through 6 Months After Booster Vaccination (Visit 7 Through Visit 9)

  An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Number of days participants missed work or school due to AE occurred following booster vaccination were reported here.

  From Visit 7 (time of booster vaccination, Month 48) Through Visit 9 (6 months after booster vaccination, Month 54)

Study Arms (1)

One group of subjects

OTHER

Procedure: blood sampling; Drug: bivalent rLP2086

Interventions

blood sampling PROCEDURE

Blood sample collection at different time points

One group of subjects

bivalent rLP2086 DRUG

A booster dose of bivalent rLP2086 at approximately 48 months following the final dose of the 2- or 3-dose primary bivalent rLP2086 vaccination series will be given at Visit 7.

One group of subjects

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
• Subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
• Subjects who completed a primary study and received all the scheduled injections within the originally planned schedule, either with bivalent rLP2086 (either 2 or 3 doses) or with investigational product in cases where subject vaccine assignment is blinded at the time of consent for study B1971033.
• Subjects who completed the blood draw following the last vaccination and subjects who completed the 6-month follow-up telephone call in the primary study.
• Evidence of a personally signed and dated ICD indicating that the subject or subject's parent(s)/legal guardian has been informed of all pertinent aspects for Visits 7 to 10 of the booster stage of the study.

You may not qualify if:

• Subject is confirmed as having received bivalent rLP2086 in the primary vaccination study.
• Subject has completed B1971033 Stage 1 and completed the Visit 6 blood draw.
• Subject is available for the entire period of the booster stage and the subject or subject's parent(s)/legal guardian can be reached by telephone.
• Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
• Male and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception through Visit 10 of the booster stage. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active. Refer to Section 4.5 for further information.
• Negative urine pregnancy test for all female subjects on the day of the booster dose.
• For subject participating in Visit 11, evidence of a personally signed and dated ICD indicating that the subject or subject's parent(s)/legal guardian has been informed of all pertinent aspects of Visit 11.
• Subject must have received 2 or 3 doses of bivalent rLP2086 in the primary study on a 0-, 2-, and 6-month or a 0- and 6-month schedule.
• Subject must have completed booster vaccination at Visit 7.
• Subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees directly involved in the conduct of the trial.
• With the exception of the primary study of bivalent rLP2086, participation in other studies within the 1-month (30-day) period before study Visit 1 and/or during study participation. Participation in purely observational studies is permitted.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation 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.
• History of culture-proven disease caused by N meningitidis or Neisseria gonorrhoeae.
• Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate blood draw.
• Receipt of any blood products, including gamma globulin, in the period from 6 months before any study visit.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (56)

Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC

Chandler, Arizona, 85224, United States

Location

Clinical Research Advantage, Inc./ East Valley Family Physicians, PLC

Chandler, Arizona, 85224, United States

Location

St. Joseph Heritage Healthcare

Huntington Beach, California, 92648, United States

Location

Center For Clinical Trials, LLC

Paramount, California, 90723, United States

Location

California Research Foundation

San Diego, California, 92123, United States

Location

Bayview Research Group

Valley Village, California, 91607, United States

Location

USF Health South Tampa Center for Advanced Healthcare

Tampa, Florida, 33606, United States

Location

USF Health

Tampa, Florida, 33606, United States

Location

North Georgia Research Clinical Center

Dalton, Georgia, 30721, United States

Location

Pediatrics and Adolescent Medicine, PA

Marietta, Georgia, 30062, United States

Location

Pediatrics And Adolescent Medicine, P.A.

Woodstock, Georgia, 30189, United States

Location

Advanced Clinical Research

Meridian, Idaho, 83642, United States

Location

Clinical Research Advantage, Inc.

Council Bluffs, Iowa, 51503, United States

Location

Heartland Research Associates, LLC

Augusta, Kansas, 67010, United States

Location

Kentucky Pediatric/Adult Research

Bardstown, Kentucky, 40004, United States

Location

U of L Pediatrics: Downtown

Louisville, Kentucky, 40202, United States

Location

Brownsboro Park Pediatrics

Louisville, Kentucky, 40207, United States

Location

Bluegrass Clinical Research, Inc.

Louisville, Kentucky, 40291, United States

Location

Southwestern Medical Clinic Lakeland Healthcare Affiliate

Stevensville, Michigan, 49127, United States

Location

The Center For Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

Clinical Research Advantage, Inc. (Prairie Fields Family Medicine, PC)

Fremont, Nebraska, 68025, United States

Location

Midwest Children's Health Research Institute

Lincoln, Nebraska, 68504, United States

Location

Creighton University Pediatric Infectious Diseases

Omaha, Nebraska, 68131, United States

Location

Clinical Research Center of Nevada,LLC

Henderson, Nevada, 89014, United States

Location

Dr. Shelly David Senders MD Inc. dba Senders Pediatrics

Cleveland, Ohio, 44121, United States

Location

Ohio Pediatric Research Association

Dayton, Ohio, 45414, United States

Location

Ohio Pediatrics, Inc

Dayton, Ohio, 45414, United States

Location

West Houston Clinical Research Service (WHCRS)

Houston, Texas, 77055, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, 84109, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States

Location

BB Holdings, LLC., dba Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

J. Lewis Research Inc, Jordan River Family Medicine

South Jordan, Utah, 84095, United States

Location

Advanced Clinical Research

West Jordan, Utah, 84088-9334, United States

Location

The Vancouver Clinic, Inc. PS

Vancouver, Washington, 98664, United States

Location

Monroe Clinic

Monroe, Wisconsin, 53566, United States

Location

Research and Education Association for Clinical Health, Inc.

Monroe, Wisconsin, 53566, United States

Location

Ordinace praktickeho lekare pro deti a dorost

Holice, 53401, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Hradec Králové, 50002, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Hradec Králové, 50004, Czechia

Location

Fakultni nemocnice Hradec Kralove

Hradec Králové, 50005, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Jindřichův Hradec, 37701, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Odolena Voda, 25070, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Pardubice, 53002, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Pardubice, 53012, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Prague, 16000, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Praha - Nusle, 14000, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Sezemice, 53304, Czechia

Location

Aarhus University hospital Skejby

Aarhus N, 8200, Denmark

Location

Jarvenpaa Vaccine Research Clinic

Jarvenpaa, 04400, Finland

Location

Pori Vaccine Research Clinic

Pori, 28100, Finland

Location

Tampere Vaccine Research Clinic

Tampere, 33100, Finland

Location

Turku Vaccine Research Clinic

Turku, 20520, Finland

Location

Kinder - und Jugendarzt Praxis

Bad Saulgau, 88348, Germany

Location

Kinderarzt Praxis

Bramsche, 49565, Germany

Location

Infektionskliniken Malarsjukhuset

Eskilstuna, 631 88, Sweden

Location

Skanes Universitetssjukhus

Malmo, 205 02, Sweden

Location

Related Publications (1)

• Vesikari T, Ostergaard L, Beeslaar J, Absalon J, Eiden JJ, Jansen KU, Jones TR, Harris SL, Maansson R, Munson S, O'Neill RE, York LJ, Perez JL. Persistence and 4-year boosting of the bactericidal response elicited by two- and three-dose schedules of MenB-FHbp: A phase 3 extension study in adolescents. Vaccine. 2019 Mar 14;37(12):1710-1719. doi: 10.1016/j.vaccine.2018.11.073. Epub 2019 Feb 12.

  PMID: 30770221 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Meningococcal Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: NONE
• Purpose: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2012
• First Posted: March 2, 2012
• Study Start: September 7, 2012
• Primary Completion: January 5, 2018
• Study Completion: January 5, 2018
• Last Updated: March 27, 2020
• Results First Posted: March 27, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share

Locations

FI (4); DE (2); SE (2); US (36); DK (1); CZ (11)