NeisVac-C Single Prime Study in Infants

Neisseria Meningitidis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01218451
• Other study ID #: 670901
• Status: Completed
• Phase: Phase 3
• First received: October 8, 2010
• Last updated: May 20, 2015
• Start date: September 2010
• Est. completion date: June 2012

Study information

• Verified date: May 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos SanitariosPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 956
• Est. completion date: June 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Weeks to 11 Weeks

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Neisseria Meningitidis

Intervention

Biological:
• 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

Locations

Country	Name	City	State
Poland	NZOZ Vitamed	Bydgoszcz
Poland	Wojewódzki Specjalistyczny Szpital Dzieciecy 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 Oddzial Pediatyczny	Lubartow
Poland	Przychodnia Medycyny Wieku Rozwojowego	Poznan
Poland	NZLA Michalkowice Jarosz i partnerzy spolka lekarska	Siemianowice
Poland	Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.	Tarnow
Poland	Szpital im. Swietej Jadwigi Slaskiej, Oddzial Dzieciecy	Trzebnica
Poland	NZOZ Zawidawie - Centrum Medyczne "Zatorska"	Wroclaw
Poland	SPSK nr 1 we Wroclawiu, Klinika Pediatrii i Chorób Infekcyjnych	Wroclaw
Spain	CSISP. Centro Superior de Investigación en Salud Pública	Almassora
Spain	CSISP. Centro Superior de Investigación en Salud Pública	Castellón de la Plana
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	Sevilla
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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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)	No
Primary	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)	No
Secondary	Antibody titers (rSBA) titers one month after completion of the primary vaccination		1 month after primary vaccination	No
Secondary	Antibody titers (rSBA titers) prior to the administration of the booster dose		Prior to booster dose	No
Secondary	Antibody titers (rSBA titers)one month after the administration of the booster dose		1 month after administration of booster dose	No
Secondary	Frequency and severity of local and systemic ractions with onset within 3 days after each vaccination		Within 3 days after vaccination	Yes
Secondary	Frequency and severity of adverse events observed during the entire follow up period		Entire follow up period	Yes