Clinical trial NCT01218451: NeisVac-C Single Prime Study in Infants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neisseria Meningitidis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-10-11
Enrollment: 956
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 1 month
measure: Number of subjects with seroprotective antibody titers (rSBA titers >= 8) prior to the administration of the booster dose
timeFrame: 6 to 9 months (from 4-6 months of age until 12-13 months of age)
measure: Number of subjects with seroprotective antibody titers (rSBA titers >= 128) 1 month after the administration of the booster dose
timeFrame: 1 month after booster dose (administered between 12-13 months of age)
Secondary outcomes:
measure: Antibody titers (rSBA) titers one month after completion of the primary vaccination
timeFrame: 1 month after primary vaccination
measure: Antibody titers (rSBA titers) prior to the administration of the booster dose
timeFrame: Prior to booster dose
measure: Antibody titers (rSBA titers)one month after the administration of the booster dose
timeFrame: 1 month after administration of booster dose
measure: Frequency and severity of local and systemic ractions with onset within 3 days after each vaccination
timeFrame: Within 3 days after vaccination
measure: Frequency and severity of adverse events observed during the entire follow up period
timeFrame: Entire follow up period
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: NZOZ Vitamed
city: Krakow
country: Poland
facility: Wojewódzki Specjalistyczny Szpital Dziecięcy im. Sw. Ludwika w Krakowie, Poradnia Pediatryczna Szczepien dla Dzieci z Grup Wysokiego Ryzyka
city: Lodz
country: Poland
facility: Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego, Oddzial Obserwacyjno-Zakazny dla Dzieci
city: Lubartow
country: Poland
facility: SP ZOZ Oddział Pediatyczny
city: Poznan
country: Poland
facility: Przychodnia Medycyny Wieku Rozwojowego
city: Siemianowice
country: Poland
facility: NZLA Michałkowice Jarosz i partnerzy spolka lekarska
city: Tarnow
country: Poland
facility: Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.
city: Trzebnica
country: Poland
facility: Szpital im. Świętej Jadwigi Śląskiej, Oddział Dziecięcy
city: Wroclaw
country: Poland
facility: SPSK nr 1 we Wrocławiu, Klinika Pediatrii i Chorób Infekcyjnych
city: Wroclaw
country: Poland
facility: NZOZ Zawidawie - Centrum Medyczne "Zatorska"
city: Almassora
country: Spain
facility: CSISP. Centro Superior de Investigación en Salud Pública
city: Castellón de la Plana
country: Spain
facility: CSISP. Centro Superior de Investigación en Salud Pública
city: Catarroja
country: Spain
facility: CSISP. Centro Superior de Investigación en Salud Pública
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: L´Eliana
country: Spain
facility: CSISP. Centro Superior de Investigación en Salud Pública
city: Puçol
country: Spain
facility: CSISP. Centro Superior de Investigación en Salud Pública
city: Quart de Poblet
country: Spain
facility: CSISP. Centro Superior de Investigación en Salud Pública
city: Sagunto
country: Spain
facility: CSISP. Centro Superior de Investigación en Salud Pública
city: Sevilla
country: Spain
facility: Instituto Hispalense de Pediatria
city: Tarragona
country: Spain
facility: Hosptial Universitario Joan XXIII de Tarragona
city: Valencia
country: Spain
facility: CSISP. Centro Superior de Investigación en Salud Pública
city: Valencia
country: Spain
facility: CSISP. Centro Superior de Investigación en Salud Pública
city: Valencia
country: Spain
facility: CSISP. Centro Superior de Investigación en Salud Pública
city: Vélez-Málaga
country: Spain
facility: Hospital Comarcal Axarquía
Study officials:
affiliation: Baxter Healthcare Corporation
name: Baxter BioScience Investigator, MD
role: STUDY_DIRECTOR
References: