NeisVac-C Single Prime Study in Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01218451
First received: October 8, 2010
Last updated: July 11, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Neisseria Meningitidis
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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • 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 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Number of subjects with seroprotective antibody titers (rSBA titers >= 8) prior to the administration of the booster dose [ Time Frame: 6 to 9 months (from 4-6 months of age until 12-13 months of age) ] [ Designated as safety issue: No ]
  • Number of subjects with seroprotective antibody titers (rSBA titers >= 128) 1 month after the administration of the booster dose [ Time Frame: 1 month after booster dose (administered between 12-13 months of age) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Antibody titers (rSBA) titers one month after completion of the primary vaccination [ Time Frame: 1 month after primary vaccination ] [ Designated as safety issue: No ]
  • Antibody titers (rSBA titers) prior to the administration of the booster dose [ Time Frame: Prior to booster dose ] [ Designated as safety issue: No ]
  • Antibody titers (rSBA titers)one month after the administration of the booster dose [ Time Frame: 1 month after administration of booster dose ] [ Designated as safety issue: No ]
  • Frequency and severity of local and systemic ractions with onset within 3 days after each vaccination [ Time Frame: Within 3 days after vaccination ] [ Designated as safety issue: Yes ]
  • Frequency and severity of adverse events observed during the entire follow up period [ Time Frame: Entire follow up period ] [ Designated as safety issue: Yes ]

Enrollment: 956
Study Start Date: September 2010
Study Completion Date: June 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Biological: Meningococcal group C polysaccharide conjugate vaccine
0.5 mL dose, subcutaneous administration in right anterolateral thigh
Other Name: NeisVac-C
Biological: Pneumococcal 13-valent conjugate vaccine
0.5 mL dose, subcutaneous administration in right anterolateral thigh
Other Name: Prevenar 13
Biological: 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 Name: Infanrix hexa
Experimental: 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
Biological: Meningococcal group C polysaccharide conjugate vaccine
0.5 mL dose, subcutaneous administration in right anterolateral thigh
Other Name: NeisVac-C
Biological: Pneumococcal 13-valent conjugate vaccine
0.5 mL dose, subcutaneous administration in right anterolateral thigh
Other Name: Prevenar 13
Biological: 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 Name: Infanrix hexa
Active Comparator: 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
Biological: Meningococcal group C polysaccharide conjugate vaccine
0.5 mL dose, subcutaneous administration in right anterolateral thigh
Other Name: NeisVac-C
Biological: Pneumococcal 13-valent conjugate vaccine
0.5 mL dose, subcutaneous administration in right anterolateral thigh
Other Name: Prevenar 13
Biological: 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 Name: Infanrix hexa

  Eligibility

Ages Eligible for Study:   8 Weeks to 11 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01218451

Locations
Poland
NZOZ Vitamed
Bydgoszcz, Poland, 85-021
Wojewódzki Specjalistyczny Szpital Dziecięcy im. Sw. Ludwika w Krakowie, Poradnia Pediatryczna Szczepien dla Dzieci z Grup Wysokiego Ryzyka
Krakow, Poland, 31-503
Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego, Oddzial Obserwacyjno-Zakazny dla Dzieci
Lodz, Poland, 91-347
SP ZOZ Oddział Pediatyczny
Lubartow, Poland, 21-100
Przychodnia Medycyny Wieku Rozwojowego
Poznan, Poland, 61-709
NZLA Michałkowice Jarosz i partnerzy spolka lekarska
Siemianowice, Poland, 41-103
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.
Tarnow, Poland, 33-100
Szpital im. Świętej Jadwigi Śląskiej, Oddział Dziecięcy
Trzebnica, Poland, 55-100
NZOZ Zawidawie - Centrum Medyczne "Zatorska"
Wroclaw, Poland, 51-315
SPSK nr 1 we Wrocławiu, Klinika Pediatrii i Chorób Infekcyjnych
Wroclaw, Poland, 50-345
Spain
CSISP. Centro Superior de Investigación en Salud Pública
Almassora, Spain, 12550
CSISP. Centro Superior de Investigación en Salud Pública
Castellón de la Plana, Spain, 12006
CSISP. Centro Superior de Investigación en Salud Pública
Catarroja, Spain, 46470
Hospital Universitario San Cecilio
Granada, Spain, 18012
CSISP. Centro Superior de Investigación en Salud Pública
L´Eliana, Spain, 46183
CSISP. Centro Superior de Investigación en Salud Pública
Puçol, Spain, 46530
CSISP. Centro Superior de Investigación en Salud Pública
Quart de Poblet, Spain, 46930
CSISP. Centro Superior de Investigación en Salud Pública
Sagunto, Spain, 46500
Instituto Hispalense de Pediatria
Sevilla, Spain, 41014
Hosptial Universitario Joan XXIII de Tarragona
Tarragona, Spain, 43007
CSISP. Centro Superior de Investigación en Salud Pública
Valencia, Spain, 46024
CSISP. Centro Superior de Investigación en Salud Pública
Valencia, Spain, 46021
CSISP. Centro Superior de Investigación en Salud Pública
Valencia, Spain, 46013
Hospital Comarcal Axarquía
Vélez-Málaga, Spain, 29700
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: Baxter BioScience Investigator, MD Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01218451     History of Changes
Other Study ID Numbers: 670901
Study First Received: October 8, 2010
Last Updated: July 11, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

ClinicalTrials.gov processed this record on October 29, 2014