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Neisseria MeningitidisPhase 3NCT01218451

NeisVac-C Single Prime Study in Infants

A Phase 3 study testing Meningococcal group C polysaccharide conjugate vaccine, Pneumococcal 13-valent conjugate vaccine and Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine in people with Neisseria Meningitidis, run by Pfizer at 24 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 8 to 11 weeksHealthy volunteers can take part
Conditions the study is for
Neisseria Meningitidis
What is being tested?
Meningococcal group C polysaccharide conjugate vaccine, Pneumococcal 13-valent conjugate vaccine and Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
956 participants
Where
24 sitesin 2 countries
Study dates
Sep 2010to Jun 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 11 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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 locations and contacts

24 sites in 2 countries.

24 sites in 2 countries

Spain14 sites

  • CSISP. Centro Superior de Investigación en Salud Pública

    Almassora, 12550

  • CSISP. Centro Superior de Investigación en Salud Pública

    Castellon, 12006

  • CSISP. Centro Superior de Investigación en Salud Pública

    Catarroja, 46470

  • Hospital Universitario San Cecilio

    Granada, 18012

  • CSISP. Centro Superior de Investigación en Salud Pública

    L'Eliana, 46183

  • CSISP. Centro Superior de Investigación en Salud Pública

    Puçol, 46530

  • CSISP. Centro Superior de Investigación en Salud Pública

    Quart de Poblet, 46930

  • CSISP. Centro Superior de Investigación en Salud Pública

    Sagunto, 46500

  • Instituto Hispalense de Pediatria

    Seville, 41014

  • Hosptial Universitario Joan XXIII de Tarragona

    Tarragona, 43007

  • CSISP. Centro Superior de Investigación en Salud Pública

    Valencia, 46013

  • CSISP. Centro Superior de Investigación en Salud Pública

    Valencia, 46021

  • CSISP. Centro Superior de Investigación en Salud Pública

    Valencia, 46024

  • Hospital Comarcal Axarquía

    Vélez-Málaga, 29700

Other trials in Spain

Poland10 sites

  • NZOZ Vitamed

    Bydgoszcz, 85-021

  • Wojewódzki Specjalistyczny Szpital Dziecięcy im. Sw. Ludwika w Krakowie, Poradnia Pediatryczna Szczepien dla Dzieci z Grup Wysokiego Ryzyka

    Krakow, 31-503

  • Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego, Oddzial Obserwacyjno-Zakazny dla Dzieci

    Lodz, 91-347

  • SP ZOZ Oddział Pediatyczny

    Lubartów, 21-100

  • Przychodnia Medycyny Wieku Rozwojowego

    Poznan, 61-709

  • NZLA Michałkowice Jarosz i partnerzy spolka lekarska

    Siemianowice Śląskie, 41-103

  • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.

    Tarnów, 33-100

  • Szpital im. Świętej Jadwigi Śląskiej, Oddział Dziecięcy

    Trzebnica, 55-100

  • SPSK nr 1 we Wrocławiu, Klinika Pediatrii i Chorób Infekcyjnych

    Wroclaw, 50-345

  • NZOZ Zawidawie - Centrum Medyczne "Zatorska"

    Wroclaw, 51-315

Other trials in Poland

About this study

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

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.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Meningococcal group C polysaccharide conjugate vaccineBiological

    Also called NeisVac-C

    0.5 mL dose, subcutaneous administration in right anterolateral thigh

  • Pneumococcal 13-valent conjugate vaccineBiological

    Also called Prevenar 13

    0.5 mL dose, subcutaneous administration in right anterolateral thigh

  • Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccineBiological

    Also called Infanrix hexa

    0.5 mL dose, subcutaneous administration in right anterolateral thigh

Study groups in NCT01218451
Study groupRoleWhat they receive
Group 1ExperimentalSingle 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
Receives: 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
Group 2ExperimentalSingle 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
Receives: 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
Group 3Active comparatorTwo 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
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 month

  2. Number of subjects with seroprotective antibody titers (rSBA titers >= 8) prior to the administration of the booster dose

    Measured: 6 to 9 months (from 4-6 months of age until 12-13 months of age)

  3. Number of subjects with seroprotective antibody titers (rSBA titers >= 128) 1 month after the administration of the booster dose

    Measured: 1 month after booster dose (administered between 12-13 months of age)

Secondary outcomes (5)

  1. Antibody titers (rSBA) titers one month after completion of the primary vaccination

    Measured: 1 month after primary vaccination

  2. Antibody titers (rSBA titers) prior to the administration of the booster dose

    Measured: Prior to booster dose

  3. Antibody titers (rSBA titers)one month after the administration of the booster dose

    Measured: 1 month after administration of booster dose

  4. Frequency and severity of local and systemic ractions with onset within 3 days after each vaccination

    Measured: Within 3 days after vaccination

  5. Frequency and severity of adverse events observed during the entire follow up period

    Measured: Entire follow up period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionJan 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
956 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01218451
Sponsor's protocol ID
670901
Status last verified
May 2015
First submitted
8 Oct 2010
Last updated
21 May 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Meningococcal group C polysaccharide conjugate vaccine, Pneumococcal 13-valent conjugate vaccine and Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine in people with Neisseria Meningitidis, run by Pfizer at 24 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Spain, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01218451.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2015; AzTrials last refreshed its copy on 1 Nov 2026.

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