NeisVac-C Single Prime Study in Infants

Pfizer

Status and phase: Completed; Phase 3

Conditions: Neisseria Meningitidis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01218451

670901

Details and patient eligibility

About

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.

Enrollment: 956 patients

Sex: All

Ages: 8 to 11 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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956 participants in 3 patient groups

Group 1

Experimental group

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

Treatment:

Biological: Pneumococcal 13-valent conjugate vaccine

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

Biological: Meningococcal group C polysaccharide conjugate vaccine

Group 2

Experimental group

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

Treatment:

Biological: Pneumococcal 13-valent conjugate vaccine

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

Biological: Meningococcal group C polysaccharide conjugate vaccine

Group 3

Active Comparator group

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

Treatment:

Biological: Pneumococcal 13-valent conjugate vaccine

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

Biological: Meningococcal group C polysaccharide conjugate vaccine