You are here

NeisVac-C Single Prime Study in Infants

Last updated on February 21, 2019

FOR MORE INFORMATION
Study Location
NZOZ Vitamed
Bydgoszcz, , 85-021 Poland
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neisseria Meningitidis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
8-11 weeks
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01218451
Pfizer
Completed
NeisVac-C Single Prime Study in Infants

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Neisseria Meningitidis
NCT01218451
All Genders
0+
Years
Multiple Sites
Neisseria Meningitidis (Bacterial Meningitis), Invasive Pneumococcal Disease (IPD)
NCT00617760
All Genders
1+
Years
Multiple Sites

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now