A Trial To Assess The Safety, Tolerability, And Immunogenicity Of Rlp2086 Vaccine When Administered In Either 2- Or 3-Dose Regimens In Healthy Subjects Aged ≥11 To <19 Years

Meningococcal Vaccine Clinical Trial

Official title:

A Phase 2, Randomized, Placebo-controlled, Single-blind Trial To Assess The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine When Administered In Either 2- Or 3-dose Regimens In Healthy Subjects Aged Greater Than Or Equal To 11 To <19 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01299480
• Other study ID #: B1971012
• Secondary ID: 6108A1-20032009-
• Status: Completed
• Phase: Phase 2
• Start date: March 3, 2011
• Est. completion date: September 18, 2012

Study information

• Verified date: October 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 well it is tolerated. This study will also look at this vaccine being given 2 or 3 times. This study will be done in healthy adolescents.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1714
• Est. completion date: September 18, 2012
• Est. primary completion date: May 3, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

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, treatment plan, 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.

• 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.

• A previous anaphylactic reaction to any vaccine or vaccine-related component.

• 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 pregnant or breastfeeding.

• Subject is a direct descendant of study site or Pfizer personnel

Related Conditions & MeSH terms

• Meningococcal Vaccine

Intervention

Biological:
• Vaccine
rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3
• Vaccine
rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2
• Vaccine
rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3
• Vaccine
rLP2086 at visits 1 and 3, saline at visits 2 and 5
• Vaccine
rLP2086 at visits 3 and 5, saline at visits 1 and 2

Locations

Country	Name	City	State
Czechia	Ordinace praktickeho lekare pro deti a dorost	Brandys nad Labem - Stara Boleslav
Czechia	Ordinace praktickeho lekare pro deti a dorost	Chlumec nad Cidlinou
Czechia	Ordinace praktickeho lekare pro deti a dorost	Holice
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czechia	Ordinace praktickeho lekare pro deti a dorost	Hradec Kralove
Czechia	Ordinace praktickeho lekare pro deti a dorost	Hradec Kralove
Czechia	Ordinace praktickeho lekare pro deti a dorost	Jindrichuv Hradec
Czechia	Ordinace praktickeho lekare pro deti a dorost	Odolena Voda
Czechia	Ordinace praktickeho lekare pro deti a dorost	Pardubice
Czechia	Ordinace praktickeho lekare pro deti a dorost	Pardubice
Czechia	Ordinace praktickeho lekare pro deti a dorost	Praha - Horni Pocernice
Czechia	Ordinace praktickeho lekare pro deti a dorost	Praha - Nusle
Czechia	Ordinace praktickeho lekare pro deti a dorost	Praha 1
Czechia	Ordinace praktickeho lekare pro deti a dorost	Praha 6
Czechia	Ordinace praktickeho lekare pro deti a dorost	Praha 6 - Petriny
Czechia	Ordinace praktickeho lekare pro deti a dorost	Sezemice
Denmark	Infektionsmedicinsk Afdeling Q	Aarhus N
Finland	Espoo Vaccine Research Clinic	Espoo
Finland	Helsinki East Vaccine Research Clinic	Helsinki
Finland	Helsinki South Vaccine Research Clinic	Helsinki
Finland	Järvenpää Vaccine Research Clinic	Järvenpää
Finland	Kokkola Vaccine Research Centre	Kokkola
Finland	Lahti Vaccine Research Clinic	Lahti
Finland	Oulu Vaccine Research Clinic	Oulu
Finland	Porin Rokotetutkimusklinikka	Pori
Finland	Seinäjoki Vaccine Research Clinic	Seinäjoki
Finland	Tampere Vaccine Research Clinic	Tampere
Finland	Turku Vaccine Research Clinic	Turku
Finland	Vantaa East Vaccine Research Clinic	Vantaa
Germany	Arztpraxis	Bad Saulgau
Germany	Kinderarzt-Praxis	Bramsche
Germany	Arztpraxis	Kleve
Germany	Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz	Mainz
Germany	Arztpraxis	Neumuenster
Germany	Kinderarztpraxis	Neumuenster
Germany	Kinderarztpraxis	Neustadt/Aisch
Poland	Gabinet Lekarski	Debica
Poland	Krakowski Szpital Specjalistyczny, im. Jana Pawla II	Krakow
Poland	NZOZ "Hipokrates-II" Sp. z o.o.	Krakow
Poland	NZOZ Salmed	Leczna
Poland	Nzoz "Anamed" S.C	Lubartow
Poland	NZOZ Praktyka Lekarza Rodzinnego Eskulap	Lublin
Poland	NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak	Oborniki Slaskie
Poland	Specjalistyczny ZOZ nad Matka i Dzieckiem,	Poznan
Poland	NZLA Michalkowice Jarosz i Partnerzy	Siemianowice Slaskie
Poland	NZOZ Nasz Lekarz	Torun
Poland	Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny	Trzebnica
Spain	Hospital Virgen Del Mar	Almeria
Spain	Cap Roquetes-Canteres	Barcelona
Spain	Institut Pediatric Mares-Riera	Blanes	Girona
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Centro de Salud de Paiporta	Paiporta	Valencia
Spain	Centro de Salud Quart de Poblet	Quart de Poblet	Valencia
Spain	Hospital General de Catalunya	Sant Cugat Del Valles	Barcelona
Spain	Cap Vila Vella	SANT Vicenç DEL Horts	Barcelona
Spain	Centro de Salud Malvarrosa	Valencia
Spain	Centro de Salud Republica Argentina	Valencia
Spain	Centro de Salud Trafalgar	Valencia
Spain	Centro Superior de Investigacion en Salud Publica	Valencia
Spain	Centro Superior de Salud Publica	Valencia
Sweden	Malarsjukhuset, Infektionsmottagningen	Eskilstuna
Sweden	Skanes Universitetssjukhus Malmo, Barn- och Ungdomscentrum	Malmo
Sweden	CRS, Clinical Research Support	Orebro

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Czechia,  Denmark,  Finland,  Germany,  Poland,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants Achieving At Least 4-fold Increase in hSBA Titer		1 month after Injection 2, 3, 4
Primary	Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation: Group 1 and 2 Participants		1 month after Injection 4
Primary	Percentage of Participants Reporting At Least 1 Adverse Event (AE)		Injection 1 up to 1 month after Injection 4
Secondary	Percentage of Participants Achieving hSBA Titer >=LLOQ: Group 3 Participants		1 month after Injection 4
Secondary	Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)		Before Injection (Inj) 1, 1 Month (M) after (aft) Injection 2, 3, 4
Secondary	Percentage of Participants Achieving hSBA Titer >=LLOQ		Before Injection 1, 1 Month after Injection 2, 3, 4
Secondary	Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level		Before Injection 1, 1 Month after Injection 2, 3, 4