Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-29 @ 10:09 AM
Study NCT ID:
NCT01218451
Status:
COMPLETED
Last Update Posted:
2015-05-21
First Post:
2010-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NeisVac-C Single Prime Study in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C538862', 'term': '13-valent pneumococcal vaccine'}, {'id': 'D004369', 'term': 'Pentetic Acid'}, {'id': 'D017325', 'term': 'Hepatitis B Vaccines'}, {'id': 'C541235', 'term': 'diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine'}], 'ancestors': [{'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D014761', 'term': 'Viral Hepatitis Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 956}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-20', 'studyFirstSubmitDate': '2010-10-08', 'studyFirstSubmitQcDate': '2010-10-08', 'lastUpdatePostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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)'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Neisseria Meningitidis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Weeks', 'minimumAge': '8 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is an infant aged 8 to 11 weeks at the time of first vaccination\n* Subject is clinically healthy as determined by the investigator's clinical judgment through collection of medical history and physical examination\n* Subject was born at full term of pregnancy (\\>= 37 weeks) with a birth weight \\>= 2 kg\n* The parent(s) or legally authorized representative of the subject provides written consent for participation\n* The parent(s) or legally authorized representative of the subject has the ability to understand and comply with the requirements of the protocol\n* The parent(s) or legally authorized representative and the subject will be available for the duration of the study\n* The parent(s) or legally authorized representative of the subject agrees to keep a subject diary\n\nExclusion Criteria:\n\n* Subject has a history of severe allergic reactions or anaphylaxis, or has a known sensitivity or allergy to any components of the vaccines\n* 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\n* Subject has a rash or dermatologic condition which may interfere with injection site reaction rating\n* Subject currently has, or has a history of, any significant cardiovascular, respiratory, hepatic, renal, metabolic, autoimmune, rheumatic, hematological, neurological, or neurodevelopmental disorder\n* 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\n* Subject has received any blood products or immunoglobulins within 60 days of study entry\n* Subject has received a live vaccine within 4 weeks or an inactivated or subunit vaccine within 2 weeks of the scheduled first vaccination\n* Subject has previously been vaccinated against meningococcal C disease\n* Subject has a known or suspected immune dysfunction\n* Subject has a functional or surgical asplenia (e.g. due to a pathologic hemoglobinopathy, leukemia, lymphoma, etc.)\n* 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\n* 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"}, 'identificationModule': {'nctId': 'NCT01218451', 'briefTitle': 'NeisVac-C Single Prime Study in Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 3b, Randomized, Open Label, Feasibility Study of a Single Priming Dose of Meningococcal Group C Conjugate Vaccine (NeisVac-C) in Infants', 'orgStudyIdInfo': {'id': '670901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': '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', 'interventionNames': ['Biological: Meningococcal group C polysaccharide conjugate vaccine', 'Biological: Pneumococcal 13-valent conjugate vaccine', 'Biological: Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': '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', 'interventionNames': ['Biological: Meningococcal group C polysaccharide conjugate vaccine', 'Biological: Pneumococcal 13-valent conjugate vaccine', 'Biological: Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3', 'description': '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', 'interventionNames': ['Biological: Meningococcal group C polysaccharide conjugate vaccine', 'Biological: Pneumococcal 13-valent conjugate vaccine', 'Biological: Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine']}], 'interventions': [{'name': 'Meningococcal group C polysaccharide conjugate vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['NeisVac-C'], 'description': '0.5 mL dose, subcutaneous administration in right anterolateral thigh', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}, {'name': 'Pneumococcal 13-valent conjugate vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Prevenar 13'], 'description': '0.5 mL dose, subcutaneous administration in right anterolateral thigh', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}, {'name': 'Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Infanrix hexa'], 'description': '0.5 mL dose, subcutaneous administration in right anterolateral thigh', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85-021', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'NZOZ Vitamed', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '31-503', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Wojewódzki Specjalistyczny Szpital Dziecięcy im. Sw. Ludwika w Krakowie, Poradnia Pediatryczna Szczepien dla Dzieci z Grup Wysokiego Ryzyka', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '91-347', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego, Oddzial Obserwacyjno-Zakazny dla Dzieci', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '21-100', 'city': 'Lubartów', 'country': 'Poland', 'facility': 'SP ZOZ Oddział Pediatyczny', 'geoPoint': {'lat': 51.46026, 'lon': 22.60952}}, {'zip': '61-709', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Przychodnia Medycyny Wieku Rozwojowego', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '41-103', 'city': 'Siemianowice Śląskie', 'country': 'Poland', 'facility': 'NZLA Michałkowice Jarosz i partnerzy spolka lekarska', 'geoPoint': {'lat': 50.32738, 'lon': 19.02901}}, {'zip': '33-100', 'city': 'Tarnów', 'country': 'Poland', 'facility': 'Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.', 'geoPoint': {'lat': 50.01381, 'lon': 20.98698}}, {'zip': '55-100', 'city': 'Trzebnica', 'country': 'Poland', 'facility': 'Szpital im. Świętej Jadwigi Śląskiej, Oddział Dziecięcy', 'geoPoint': {'lat': 51.31076, 'lon': 17.06331}}, {'zip': '50-345', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'SPSK nr 1 we Wrocławiu, Klinika Pediatrii i Chorób Infekcyjnych', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '51-315', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'NZOZ Zawidawie - Centrum Medyczne "Zatorska"', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '12550', 'city': 'Almassora', 'country': 'Spain', 'facility': 'CSISP. Centro Superior de Investigación en Salud Pública', 'geoPoint': {'lat': 39.94729, 'lon': -0.06313}}, {'zip': '12006', 'city': 'Castellon', 'country': 'Spain', 'facility': 'CSISP. Centro Superior de Investigación en Salud Pública', 'geoPoint': {'lat': 39.98567, 'lon': -0.04935}}, {'zip': '46470', 'city': 'Catarroja', 'country': 'Spain', 'facility': 'CSISP. Centro Superior de Investigación en Salud Pública', 'geoPoint': {'lat': 39.4, 'lon': -0.4}}, {'zip': '18012', 'city': 'Granada', 'country': 'Spain', 'facility': 'Hospital Universitario San Cecilio', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '46183', 'city': "L'Eliana", 'country': 'Spain', 'facility': 'CSISP. Centro Superior de Investigación en Salud Pública', 'geoPoint': {'lat': 39.56667, 'lon': -0.53333}}, {'zip': '46530', 'city': 'Puçol', 'country': 'Spain', 'facility': 'CSISP. Centro Superior de Investigación en Salud Pública', 'geoPoint': {'lat': 39.61667, 'lon': -0.3}}, {'zip': '46930', 'city': 'Quart de Poblet', 'country': 'Spain', 'facility': 'CSISP. Centro Superior de Investigación en Salud Pública', 'geoPoint': {'lat': 39.48139, 'lon': -0.43937}}, {'zip': '46500', 'city': 'Sagunto', 'country': 'Spain', 'facility': 'CSISP. Centro Superior de Investigación en Salud Pública', 'geoPoint': {'lat': 39.68333, 'lon': -0.26667}}, {'zip': '41014', 'city': 'Seville', 'country': 'Spain', 'facility': 'Instituto Hispalense de Pediatria', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '43007', 'city': 'Tarragona', 'country': 'Spain', 'facility': 'Hosptial Universitario Joan XXIII de Tarragona', 'geoPoint': {'lat': 41.11905, 'lon': 1.24544}}, {'zip': '46013', 'city': 'Valencia', 'country': 'Spain', 'facility': 'CSISP. Centro Superior de Investigación en Salud Pública', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46021', 'city': 'Valencia', 'country': 'Spain', 'facility': 'CSISP. Centro Superior de Investigación en Salud Pública', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46024', 'city': 'Valencia', 'country': 'Spain', 'facility': 'CSISP. Centro Superior de Investigación en Salud Pública', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '29700', 'city': 'Vélez-Málaga', 'country': 'Spain', 'facility': 'Hospital Comarcal Axarquía', 'geoPoint': {'lat': 36.78107, 'lon': -4.10266}}], 'overallOfficials': [{'name': 'Baxter BioScience Investigator, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Baxter Healthcare Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}