Neisseria Meningitidis Clinical Trial
Official title:
A Phase 3b, Randomized, Open Label, Feasibility Study of a Single Priming Dose of Meningococcal Group C Conjugate Vaccine (NeisVac-C) in Infants
The purpose of this study is to assess the feasibility of a single priming dose of NeisVac-C in infants (at either 4 or 6 months of age), as determined by immune response.
Status | Completed |
Enrollment | 956 |
Est. completion date | June 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 8 Weeks to 11 Weeks |
Eligibility |
Inclusion Criteria: - Subject is an infant aged 8 to 11 weeks at the time of first vaccination - Subject is clinically healthy as determined by the investigator's clinical judgment through collection of medical history and physical examination - Subject was born at full term of pregnancy (>= 37 weeks) with a birth weight >= 2 kg - The parent(s) or legally authorized representative of the subject provides written consent for participation - The parent(s) or legally authorized representative of the subject has the ability to understand and comply with the requirements of the protocol - The parent(s) or legally authorized representative and the subject will be available for the duration of the study - The parent(s) or legally authorized representative of the subject agrees to keep a subject diary Exclusion Criteria: - Subject has a history of severe allergic reactions or anaphylaxis, or has a known sensitivity or allergy to any components of the vaccines - Subject has had an acute or chronic infection requiring systemic therapy (antibiotic or antiviral) or other prescribed treatment within the 2 weeks prior to the first vaccination in this study - Subject has a rash or dermatologic condition which may interfere with injection site reaction rating - Subject currently has, or has a history of, any significant cardiovascular, respiratory, hepatic, renal, metabolic, autoimmune, rheumatic, hematological, neurological, or neurodevelopmental disorder - Subject has a disease, or is currently undergoing a form of treatment, or was undergoing a form of treatment within 30 days prior to study entry, that could be expected to influence immune response - Subject has received any blood products or immunoglobulins within 60 days of study entry - Subject has received a live vaccine within 4 weeks or an inactivated or subunit vaccine within 2 weeks of the scheduled first vaccination - Subject has previously been vaccinated against meningococcal C disease - Subject has a known or suspected immune dysfunction - Subject has a functional or surgical asplenia (e.g. due to a pathologic hemoglobinopathy, leukemia, lymphoma, etc.) - Subject was administered an investigational drug within six weeks prior to study entry or is concurrently participating in a clinical study that includes the administration of an investigational product - Subject or his/her parent(s) / legally authorized representative are in a dependent relationship with the study investigator or with a study team member; dependent relationships include close relatives (i.e. children, partner/spouse, siblings) as well as employees of the investigator or site conducting the study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Poland | NZOZ Vitamed | Bydgoszcz | |
Poland | Wojewódzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie, Poradnia Pediatryczna Szczepien dla Dzieci z Grup Wysokiego Ryzyka | Krakow | |
Poland | Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego, Oddzial Obserwacyjno-Zakazny dla Dzieci | Lodz | |
Poland | SP ZOZ Oddzial Pediatyczny | Lubartow | |
Poland | Przychodnia Medycyny Wieku Rozwojowego | Poznan | |
Poland | NZLA Michalkowice Jarosz i partnerzy spolka lekarska | Siemianowice | |
Poland | Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o. | Tarnow | |
Poland | Szpital im. Swietej Jadwigi Slaskiej, Oddzial Dzieciecy | Trzebnica | |
Poland | NZOZ Zawidawie - Centrum Medyczne "Zatorska" | Wroclaw | |
Poland | SPSK nr 1 we Wroclawiu, Klinika Pediatrii i Chorób Infekcyjnych | Wroclaw | |
Spain | CSISP. Centro Superior de Investigación en Salud Pública | Almassora | |
Spain | CSISP. Centro Superior de Investigación en Salud Pública | Castellón de la Plana | |
Spain | CSISP. Centro Superior de Investigación en Salud Pública | Catarroja | |
Spain | Hospital Universitario San Cecilio | Granada | |
Spain | CSISP. Centro Superior de Investigación en Salud Pública | L´Eliana | |
Spain | CSISP. Centro Superior de Investigación en Salud Pública | Puçol | |
Spain | CSISP. Centro Superior de Investigación en Salud Pública | Quart de Poblet | |
Spain | CSISP. Centro Superior de Investigación en Salud Pública | Sagunto | |
Spain | Instituto Hispalense de Pediatria | Sevilla | |
Spain | Hosptial Universitario Joan XXIII de Tarragona | Tarragona | |
Spain | CSISP. Centro Superior de Investigación en Salud Pública | Valencia | |
Spain | CSISP. Centro Superior de Investigación en Salud Pública | Valencia | |
Spain | CSISP. Centro Superior de Investigación en Salud Pública | Valencia | |
Spain | Hospital Comarcal Axarquía | Vélez-Málaga |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Poland, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of subjects with seroprotective antibody titers (rSBA titers >= 8) 1 month after completion of the primary vaccination in single-dose groups compared to the two-dose group | 1 month | No | |
Primary | Number of subjects with seroprotective antibody titers (rSBA titers >= 8) prior to the administration of the booster dose | 6 to 9 months (from 4-6 months of age until 12-13 months of age) | No | |
Primary | Number of subjects with seroprotective antibody titers (rSBA titers >= 128) 1 month after the administration of the booster dose | 1 month after booster dose (administered between 12-13 months of age) | No | |
Secondary | Antibody titers (rSBA) titers one month after completion of the primary vaccination | 1 month after primary vaccination | No | |
Secondary | Antibody titers (rSBA titers) prior to the administration of the booster dose | Prior to booster dose | No | |
Secondary | Antibody titers (rSBA titers)one month after the administration of the booster dose | 1 month after administration of booster dose | No | |
Secondary | Frequency and severity of local and systemic ractions with onset within 3 days after each vaccination | Within 3 days after vaccination | Yes | |
Secondary | Frequency and severity of adverse events observed during the entire follow up period | Entire follow up period | Yes |
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