NeisVac-C Single Prime Study in Infants

May 20, 2015 updated by: Pfizer

A Phase 3b, Randomized, Open Label, Feasibility Study of a Single Priming Dose of Meningococcal Group C Conjugate Vaccine (NeisVac-C) in Infants

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
956

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Bydgoszcz, Poland, 85-021
        • NZOZ Vitamed
      • Krakow, Poland, 31-503
        • Wojewódzki Specjalistyczny Szpital Dziecięcy im. Sw. Ludwika w Krakowie, Poradnia Pediatryczna Szczepien dla Dzieci z Grup Wysokiego Ryzyka
      • Lodz, Poland, 91-347
        • Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego, Oddzial Obserwacyjno-Zakazny dla Dzieci
      • Lubartow, Poland, 21-100
        • SP ZOZ Oddział Pediatyczny
      • Poznan, Poland, 61-709
        • Przychodnia Medycyny Wieku Rozwojowego
      • Siemianowice, Poland, 41-103
        • NZLA Michałkowice Jarosz i partnerzy spolka lekarska
      • Tarnow, Poland, 33-100
        • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. Z O.O.
      • Trzebnica, Poland, 55-100
        • Szpital im. Świętej Jadwigi Śląskiej, Oddział Dziecięcy
      • Wroclaw, Poland, 50-345
        • SPSK nr 1 we Wrocławiu, Klinika Pediatrii i Chorób Infekcyjnych
      • Wroclaw, Poland, 51-315
        • NZOZ Zawidawie - Centrum Medyczne "Zatorska"
  • Spain
      • Almassora, Spain, 12550
        • CSISP. Centro Superior de Investigación en Salud Pública
      • Castellón de la Plana, Spain, 12006
        • CSISP. Centro Superior de Investigación en Salud Pública
      • Catarroja, Spain, 46470
        • CSISP. Centro Superior de Investigación en Salud Pública
      • Granada, Spain, 18012
        • Hospital Universitario San Cecilio
      • L´Eliana, Spain, 46183
        • CSISP. Centro Superior de Investigación en Salud Pública
      • Puçol, Spain, 46530
        • CSISP. Centro Superior de Investigación en Salud Pública
      • Quart de Poblet, Spain, 46930
        • CSISP. Centro Superior de Investigación en Salud Pública
      • Sagunto, Spain, 46500
        • CSISP. Centro Superior de Investigación en Salud Pública
      • Sevilla, Spain, 41014
        • Instituto Hispalense de Pediatria
      • Tarragona, Spain, 43007
        • Hosptial Universitario Joan XXIII de Tarragona
      • Valencia, Spain, 46013
        • CSISP. Centro Superior de Investigación en Salud Pública
      • Valencia, Spain, 46021
        • CSISP. Centro Superior de Investigación en Salud Pública
      • Valencia, Spain, 46024
        • CSISP. Centro Superior de Investigación en Salud Pública
      • Vélez-Málaga, Spain, 29700
        • Hospital Comarcal Axarquía

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 month to 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Biological: Meningococcal group C polysaccharide conjugate vaccine
0.5 mL dose, subcutaneous administration in right anterolateral thigh
Other Names:
  • NeisVac-C
Biological: Pneumococcal 13-valent conjugate vaccine
0.5 mL dose, subcutaneous administration in right anterolateral thigh
Other Names:
  • 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 Names:
  • Infanrix hexa
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
Biological: Meningococcal group C polysaccharide conjugate vaccine
0.5 mL dose, subcutaneous administration in right anterolateral thigh
Other Names:
  • NeisVac-C
Biological: Pneumococcal 13-valent conjugate vaccine
0.5 mL dose, subcutaneous administration in right anterolateral thigh
Other Names:
  • 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 Names:
  • Infanrix hexa
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
Biological: Meningococcal group C polysaccharide conjugate vaccine
0.5 mL dose, subcutaneous administration in right anterolateral thigh
Other Names:
  • NeisVac-C
Biological: Pneumococcal 13-valent conjugate vaccine
0.5 mL dose, subcutaneous administration in right anterolateral thigh
Other Names:
  • 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 Names:
  • Infanrix hexa

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Time Frame: 1 month
1 month
Number of subjects with seroprotective antibody titers (rSBA titers >= 8) prior to the administration of the booster dose
Time Frame: 6 to 9 months (from 4-6 months of age until 12-13 months of age)
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
Time Frame: 1 month after booster dose (administered between 12-13 months of age)
1 month after booster dose (administered between 12-13 months of age)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Antibody titers (rSBA) titers one month after completion of the primary vaccination
Time Frame: 1 month after primary vaccination
1 month after primary vaccination
Antibody titers (rSBA titers) prior to the administration of the booster dose
Time Frame: Prior to booster dose
Prior to booster dose
Antibody titers (rSBA titers)one month after the administration of the booster dose
Time Frame: 1 month after administration of 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
Time Frame: Within 3 days after vaccination
Within 3 days after vaccination
Frequency and severity of adverse events observed during the entire follow up period
Time Frame: Entire follow up period
Entire follow up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Baxter BioScience Investigator, MD, Baxter Healthcare Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 670901

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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