A Study to Describe the Immunogenicity, Safety, and Tolerability of Neisseria Meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Subjects Aged ≥24 Months to <10 Years

PHASE2CompletedINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

August 31, 2015

Primary Completion Date

March 31, 2017

Study Completion Date

March 31, 2017

Conditions
MENINGOCOCCAL INFECTION
Interventions
BIOLOGICAL

Bivalent rLP2086 Vaccine

1 dose of 120 μg of bivalent rLP2086 by intramuscular injection at Months 0, 2, and 6 into the upper deltoid muscle of the arm.

BIOLOGICAL

Licensed pediatric hepatits A vaccine

1 0.5 mL dose by intramuscular injection at Months 0 and 6 into the upper deltoid muscle of the arm.

OTHER

Normal Saline

Sterile saline solution for injection (0.85% sodium chloride) in a 0.5 mL dose at Month 2.

Trial Locations (15)

20520

Turku Vaccine Research Center, Turku

Turku Vaccine Research Clinic, Turku

28100

Pori Vaccine Research Clinic, Pori

33100

Tampere Vaccine Research Clinic, Tampere

90220

Oulu Vaccine Research Clinic, Oulu

02230

Espoo Vaccine Research Clinic, Espoo

00100

Helsinki South Vaccine Research Clinic, Helsinki

39-200

Prywatny Gabinet Lekarski dr n. med. Jerzy Brzostek, Dębica

55-093

Praktyka Lekarza Rodzinnego-Slawin Sp. z o.o., Kiełczów

31- 202

Krakowski Szpital Specjalistyczny im. Jana Pawla II, Krakow

31-302

Hanna Czajka - Indywidualna Specjalistyczna Praktyka Lekarska, Krakow

61-709

Specjalistyczna Przychodnia Medycyny Wieku Rozwojowego, Poznan

41-103

"Niepubliczny Zaklad Lecznictwa Ambulatoryjnego MichalkowiceJarosz i Partnerzy Spolka Lekarska", Siemianowice Śląskie

50-368

Samodzielny Publiczny Szpital Kliniczny Nr 1 We Wroclawiu, Wroclaw

21-010

Niepubliczny Zaklad Opieki Zdrowotnej Salmed S. C., Łęczna

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT02531698 - A Study to Describe the Immunogenicity, Safety, and Tolerability of Neisseria Meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Subjects Aged ≥24 Months to <10 Years | Biotech Hunter | Biotech Hunter