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NeisVac-C Single Prime Study in Infants

Last updated on December 1, 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

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Descriptive Information
Brief Title  ICMJE NeisVac-C Single Prime Study in Infants
Official Title  ICMJE A Phase 3b, Randomized, Open Label, Feasibility Study of a Single Priming Dose of Meningococcal Group C Conjugate Vaccine (NeisVac-C) in Infants
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Neisseria Meningitidis
Intervention  ICMJE
  • Biological: Meningococcal group C polysaccharide conjugate vaccine
    0.5 mL dose, subcutaneous administration in right anterolateral thigh
    Other Name: NeisVac-C
  • Biological: Pneumococcal 13-valent conjugate vaccine
    0.5 mL dose, subcutaneous administration in right anterolateral thigh
    Other Name: 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 Name: Infanrix hexa
Study Arms  ICMJE
  • 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
    Interventions:
    • 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
  • 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
    Interventions:
    • 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
  • 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
    Interventions:
    • 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
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2012)
956
Original Estimated Enrollment  ICMJE
 (submitted: October 8, 2010)
948
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion DateJanuary 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 8 Weeks to 11 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01218451
Other Study ID Numbers  ICMJE 670901
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Baxter BioScience Investigator, MDBaxter Healthcare Corporation
PRS AccountPfizer
Verification DateMay 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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]

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