Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
956 participants
INTERVENTIONAL
2010-09-30
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group 1
Single dose of NeisVac-C vaccine at 4 months of age - Concomitant vaccinations of Infanrix hexa (0.5 mL) and Prevenar 13 (0.5 mL) at 2, 4 and 6 months of age - Booster vaccination with NeisVac-C, Infanrix hexa and Prevenar between 12 and 13 months of age
Meningococcal group C polysaccharide conjugate vaccine
0.5 mL dose, subcutaneous administration in right anterolateral thigh
Pneumococcal 13-valent conjugate vaccine
0.5 mL dose, subcutaneous administration in right anterolateral thigh
Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine
0.5 mL dose, subcutaneous administration in right anterolateral thigh
Group 2
Single dose of NeisVac-C vaccine at 6 months of age - Concomitant vaccinations of Infanrix hexa (0.5 mL) and Prevenar 13 (0.5 mL) at 2, 4 and 6 months of age - Booster vaccination with NeisVac-C, Infanrix hexa and Prevenar between 12 and 13 months of age
Meningococcal group C polysaccharide conjugate vaccine
0.5 mL dose, subcutaneous administration in right anterolateral thigh
Pneumococcal 13-valent conjugate vaccine
0.5 mL dose, subcutaneous administration in right anterolateral thigh
Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine
0.5 mL dose, subcutaneous administration in right anterolateral thigh
Group 3
Two doses of NeisVac-C vaccine at 2 and 4 months of age - Concomitant vaccinations of Infanrix hexa (0.5 mL) and Prevenar 13 (0.5 mL) at 2, 4 and 6 months of age - Booster vaccination with NeisVac-C, Infanrix hexa and Prevenar between 12 and 13 months of age
Meningococcal group C polysaccharide conjugate vaccine
0.5 mL dose, subcutaneous administration in right anterolateral thigh
Pneumococcal 13-valent conjugate vaccine
0.5 mL dose, subcutaneous administration in right anterolateral thigh
Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine
0.5 mL dose, subcutaneous administration in right anterolateral thigh
Interventions
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Meningococcal group C polysaccharide conjugate vaccine
0.5 mL dose, subcutaneous administration in right anterolateral thigh
Pneumococcal 13-valent conjugate vaccine
0.5 mL dose, subcutaneous administration in right anterolateral thigh
Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine
0.5 mL dose, subcutaneous administration in right anterolateral thigh
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
8 Weeks
11 Weeks
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Baxter BioScience Investigator, MD
Role: STUDY_DIRECTOR
Baxter Healthcare Corporation
Locations
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NZOZ Vitamed
Bydgoszcz, , Poland
Wojewódzki Specjalistyczny Szpital Dziecięcy 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 Oddział Pediatyczny
Lubartów, , Poland
Przychodnia Medycyny Wieku Rozwojowego
Poznan, , Poland
NZLA Michałkowice Jarosz i partnerzy spolka lekarska
Siemianowice Śląskie, , Poland
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.
Tarnów, , Poland
Szpital im. Świętej Jadwigi Śląskiej, Oddział Dziecięcy
Trzebnica, , Poland
SPSK nr 1 we Wrocławiu, Klinika Pediatrii i Chorób Infekcyjnych
Wroclaw, , Poland
NZOZ Zawidawie - Centrum Medyczne "Zatorska"
Wroclaw, , Poland
CSISP. Centro Superior de Investigación en Salud Pública
Almassora, , Spain
CSISP. Centro Superior de Investigación en Salud Pública
Castellon, , 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
Seville, , 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, , Spain
Countries
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Other Identifiers
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670901
Identifier Type: -
Identifier Source: org_study_id
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