NeisVac-C Single Prime Study in Infants

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.

Study Overview

• Status: Completed
• Conditions: Neisseria Meningitidis
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 956
• Phase: Phase 3

Contacts and Locations

Study Locations

• Poland
  • Bydgoszcz, Poland, 85-021
    • NZOZ Vitamed
  • Krakow, Poland, 31-503
    • Wojewódzki Specjalistyczny Szpital Dziecięcy im. Sw. Ludwika w Krakowie, Poradnia Pediatryczna Szczepien dla Dzieci z Grup Wysokiego Ryzyka
  • Lodz, Poland, 91-347
    • Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego, Oddzial Obserwacyjno-Zakazny dla Dzieci
  • Lubartow, Poland, 21-100
    • SP ZOZ Oddział Pediatyczny
  • Poznan, Poland, 61-709
    • Przychodnia Medycyny Wieku Rozwojowego
  • Siemianowice, Poland, 41-103
    • NZLA Michałkowice Jarosz i partnerzy spolka lekarska
  • Tarnow, Poland, 33-100
    • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. Z O.O.
  • Trzebnica, Poland, 55-100
    • Szpital im. Świętej Jadwigi Śląskiej, Oddział Dziecięcy
  • Wroclaw, Poland, 50-345
    • SPSK nr 1 we Wrocławiu, Klinika Pediatrii i Chorób Infekcyjnych
  • Wroclaw, Poland, 51-315
    • NZOZ Zawidawie - Centrum Medyczne "Zatorska"
• Spain
  • 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
    • CSISP. Centro Superior de Investigación en Salud Pública
  • Granada, Spain, 18012
    • Hospital Universitario San Cecilio
  • 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
    • CSISP. Centro Superior de Investigación en Salud Pública
  • Sevilla, Spain, 41014
    • Instituto Hispalense de Pediatria
  • Tarragona, Spain, 43007
    • Hosptial Universitario Joan XXIII de Tarragona
  • Valencia, Spain, 46013
    • CSISP. Centro Superior de Investigación en Salud Pública
  • Valencia, Spain, 46021
    • CSISP. Centro Superior de Investigación en Salud Pública
  • Valencia, Spain, 46024
    • CSISP. Centro Superior de Investigación en Salud Pública
  • Vélez-Málaga, Spain, 29700
    • Hospital Comarcal Axarquía

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: NeisVac-C; Biological: Pneumococcal 13-valent conjugate vaccine; 0.5 mL dose, subcutaneous administration in right anterolateral thigh; Other Names: 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 Names: 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 Names: NeisVac-C; Biological: Pneumococcal 13-valent conjugate vaccine; 0.5 mL dose, subcutaneous administration in right anterolateral thigh; Other Names: 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 Names: 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 Names: NeisVac-C; Biological: Pneumococcal 13-valent conjugate vaccine; 0.5 mL dose, subcutaneous administration in right anterolateral thigh; Other Names: 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 Names: Infanrix hexa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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)
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)

Secondary Outcome Measures

Outcome Measure	Time Frame
Antibody titers (rSBA) titers one month after completion of the primary vaccination	1 month after primary vaccination
Antibody titers (rSBA titers) prior to the administration of the booster dose	Prior to booster dose
Antibody titers (rSBA titers)one month after the administration of the booster dose	1 month after administration of booster dose
Frequency and severity of local and systemic ractions with onset within 3 days after each vaccination	Within 3 days after vaccination
Frequency and severity of adverse events observed during the entire follow up period	Entire follow up period

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Baxter BioScience Investigator, MD, Baxter Healthcare Corporation

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: October 8, 2010
• First Submitted That Met QC Criteria: October 8, 2010
• First Posted (Estimate): October 11, 2010

Study Record Updates

• Last Update Posted (Estimate): May 21, 2015
• Last Update Submitted That Met QC Criteria: May 20, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 670901

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No