NeisVac-C Single Prime Study in Infants

NCT01218451 | Completed Phase 3 DMC

• 1 other identifier: 670901
• Study Type: interventional
• Target: 956
• Locations: 2 countries
• Sites: 24

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.

Conditions

Neisseria Meningitidis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

Study Arms (3)

Group 1

EXPERIMENTAL

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; Biological: Pneumococcal 13-valent conjugate vaccine; Biological: Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine

Group 2

EXPERIMENTAL

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; Biological: Pneumococcal 13-valent conjugate vaccine; Biological: Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine

Group 3

ACTIVE COMPARATOR

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; Biological: Pneumococcal 13-valent conjugate vaccine; Biological: Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine

Interventions

Meningococcal group C polysaccharide conjugate vaccine BIOLOGICAL

0.5 mL dose, subcutaneous administration in right anterolateral thigh

Also known as: NeisVac-C

Group 1; Group 2; Group 3

Pneumococcal 13-valent conjugate vaccine BIOLOGICAL

0.5 mL dose, subcutaneous administration in right anterolateral thigh

Also known as: Prevenar 13

Group 1; Group 2; Group 3

Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine BIOLOGICAL

0.5 mL dose, subcutaneous administration in right anterolateral thigh

Also known as: Infanrix hexa

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 8 Weeks - 11 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (24)

NZOZ Vitamed

Bydgoszcz, 85-021, Poland

Location

Wojewódzki Specjalistyczny Szpital Dziecięcy im. Sw. Ludwika w Krakowie, Poradnia Pediatryczna Szczepien dla Dzieci z Grup Wysokiego Ryzyka

Krakow, 31-503, Poland

Location

Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego, Oddzial Obserwacyjno-Zakazny dla Dzieci

Lodz, 91-347, Poland

Location

SP ZOZ Oddział Pediatyczny

Lubartów, 21-100, Poland

Location

Przychodnia Medycyny Wieku Rozwojowego

Poznan, 61-709, Poland

Location

NZLA Michałkowice Jarosz i partnerzy spolka lekarska

Siemianowice Śląskie, 41-103, Poland

Location

Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.

Tarnów, 33-100, Poland

Location

Szpital im. Świętej Jadwigi Śląskiej, Oddział Dziecięcy

Trzebnica, 55-100, Poland

Location

SPSK nr 1 we Wrocławiu, Klinika Pediatrii i Chorób Infekcyjnych

Wroclaw, 50-345, Poland

Location

NZOZ Zawidawie - Centrum Medyczne "Zatorska"

Wroclaw, 51-315, Poland

Location

CSISP. Centro Superior de Investigación en Salud Pública

Almassora, 12550, Spain

Location

CSISP. Centro Superior de Investigación en Salud Pública

Castellon, 12006, Spain

Location

CSISP. Centro Superior de Investigación en Salud Pública

Catarroja, 46470, Spain

Location

Hospital Universitario San Cecilio

Granada, 18012, Spain

Location

CSISP. Centro Superior de Investigación en Salud Pública

L'Eliana, 46183, Spain

Location

CSISP. Centro Superior de Investigación en Salud Pública

Puçol, 46530, Spain

Location

CSISP. Centro Superior de Investigación en Salud Pública

Quart de Poblet, 46930, Spain

Location

CSISP. Centro Superior de Investigación en Salud Pública

Sagunto, 46500, Spain

Location

Instituto Hispalense de Pediatria

Seville, 41014, Spain

Location

Hosptial Universitario Joan XXIII de Tarragona

Tarragona, 43007, Spain

Location

CSISP. Centro Superior de Investigación en Salud Pública

Valencia, 46013, Spain

Location

CSISP. Centro Superior de Investigación en Salud Pública

Valencia, 46021, Spain

Location

CSISP. Centro Superior de Investigación en Salud Pública

Valencia, 46024, Spain

Location

Hospital Comarcal Axarquía

Vélez-Málaga, 29700, Spain

Location

MeSH Terms

Interventions

13-valent pneumococcal vaccine; Pentetic Acid; Hepatitis B Vaccines; diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Baxter BioScience Investigator, MD

  Baxter Healthcare Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: October 11, 2010
• Study Start: September 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 21, 2015

Record last verified: 2015-05

Locations

PL (10); ES (14)