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.

Meningitis Clinical Trial

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 Greater Than Or Equal To 11 To <19 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323270
• Other study ID #: B1971010
• Secondary ID: 6108A1-20082010-
• Status: Completed
• Phase: Phase 2
• Start date: March 18, 2011
• Est. completion date: February 19, 2013

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 it is tolerated when given together with Repevax. The study will be done in healthy adolescents.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 753
• Est. completion date: February 19, 2013
• Est. primary completion date: October 8, 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, 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.

Related Conditions & MeSH terms

• Meningitis
• Meningococcal Vaccine
• N Meningitidis Serogroup B
• Repevax
• rLP2086

Intervention

Biological:
• rLP2086
0.5 mL dose, given at 0, 2 and 6 months.
• Repevax
0.5 mL dose, given at 0 months.
• Saline
0.5 mL dose, given at 0, 2 and 6 months.
• Repevax
0.5 mL dose, given at 0 months.

Locations

Country	Name	City	State
Finland	Espoo Vaccine Research Clinic	Espoo
Finland	Helsinki South Vaccine Research Clinic	Helsinki
Finland	Ita-Helsinki Vaccine Research Clinic	Helsinki
Finland	Järvenpää Vaccine Research Clinic	Järvenpää
Finland	Kokkola Vaccine Research Clinic	Kokkola
Finland	Lahti Vaccine Research Clinic	Lahti
Finland	Oulu Vaccine Research Clinic	Oulu
Finland	Pori Vaccine Research Clinic	Pori
Finland	Seinäjoki Vaccine Research Clinic	Seinäjoki
Finland	Tampere Vaccine Research Clinic	Tampere
Finland	Tampereen Yliopisto University Of Tampere	Tampere
Finland	Vaccine Research Center	Tampere
Finland	Turku Vaccine Research Clinic	Turku
Finland	Vantaa Vaccine Research Clinic	Vantaa
Germany	Gemeinschaftspraxis Dr. med. Guido Hein, Dr. med. Rainer Lauf	Bad Sobernheim
Germany	Gerhard Bleckmann Kinder- und Jugendarzt	Baunatal
Germany	Kinderarzt-Praxis	Bramsche
Germany	Gemeinschaftspraxis fuer Kinder- und Jugendmedizin Dres. Behre, Burgert, Gunkel	Kehl
Germany	Dr. med. Sobhi Mahdi Kinderarzt und Jugendmedizin	Luebeck
Germany	Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz	Mainz
Germany	Dr. Michael Vomstein, Hermann Oesterle, Kinder- und Jugendaerzte	Schwaebisch-Hall
Germany	Thomas Lenz & (Frau) Dr. med. Marin Eggers	Vellmar
Germany	Dres.T. Schmitz, H. Knee, Ch, Wittermann Fachaerztliche	Weilheim
Germany	Gemeinschaftspraxis fuer Kinder und Jugendliche Welzheim	Welzheim
Poland	Gabinet Lekarski	Debica
Poland	Krakowski Szpital Specjalistyczny, im. Jana Pawla II	Krakow
Poland	NZOZ Salmed	Leczna
Poland	Specjalistyczna Praktyka Lekarska Gravita	Lodz
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Oddzial Pediatryczny	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, Przychodnia Wieku Rozwojowego	Poznan
Poland	NZLA Michalkowice Jarosz i Partnerzy	Siemianowice Slaskie
Poland	NZOZ Nasz Lekarz	Torun
Poland	Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny	Trzebnica
Poland	Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Finland,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immunoglobulin G (IgG) Measured by Geometric Mean Titer (GMT)		Before vaccination 1, 1 month after Vaccination 2, 3
Other	Geometric Mean Fold-Rise (GMFR) for IgG		Before Vaccination 1, 1 month after Vaccination 2, 3
Primary	Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen		1 month after Vaccination 1
Primary	Percentage of Participants With at Least One Adverse Event (AE)		Vaccination 1 up to 1 month after Vaccination 3
Secondary	Geometric Mean Concentration (GMC) for Diphtheria and Tetanus Antigens		1 month after Vaccination 1
Secondary	GMC for Acellular Pertussis Antigens	Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL)	1 month after Vaccination 1
Secondary	Geometric Mean Titer (GMT) for Poliomyelitis Antigens		1 month after Vaccination 1
Secondary	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