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CompletedNCT01218451Updated May 21, 2015

NeisVac-C Single Prime Study in Infants

A Phase 3 interventional study of Meningococcal group C polysaccharide conjugate vaccine and Pneumococcal 13-valent conjugate vaccine in Neisseria Meningitidis, sponsored by Pfizer. Completed at 24 sites in 2 countries. Open to participants aged 8 Weeks to 11 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-21.

Sponsored by Pfizer · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
956
Allocation
Randomized
Ages
8 Weeks to 11 Weeks
Sex
All
01

Study 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.

02

Conditions studied

  • Neisseria Meningitidis
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.

Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Browse Pfizer studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Weeks to 11 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
956 participants (actual)

Study arms

  • 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 · 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

    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

    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

Interventions

  • BiologicalMeningococcal group C polysaccharide conjugate vaccine

    0.5 mL dose, subcutaneous administration in right anterolateral thigh

    Also known as: NeisVac-C

  • BiologicalPneumococcal 13-valent conjugate vaccine

    0.5 mL dose, subcutaneous administration in right anterolateral thigh

    Also known as: Prevenar 13

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

    Drug page: Pentetic Acid

    0.5 mL dose, subcutaneous administration in right anterolateral thigh

    Also known as: Infanrix hexa

06

What researchers measure

Primary outcomes

  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

    Time frame: 1 month

  2. 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)

  3. 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)

Secondary outcomes

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

    Time frame: 1 month after primary vaccination

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

    Time frame: Prior to booster dose

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

    Time frame: 1 month after administration of booster dose

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

    Time frame: Within 3 days after vaccination

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

    Time frame: Entire follow up period

07

Study locations

24 sites
  • NZOZ Vitamed
    Bydgoszcz, 85-021, Poland
  • Wojewódzki Specjalistyczny Szpital Dziecięcy im. Sw. Ludwika w Krakowie, Poradnia Pediatryczna Szczepien dla Dzieci z Grup Wysokiego Ryzyka
    Krakow, 31-503, Poland
  • Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego, Oddzial Obserwacyjno-Zakazny dla Dzieci
    Lodz, 91-347, Poland
  • SP ZOZ Oddział Pediatyczny
    Lubartów, 21-100, Poland
  • Przychodnia Medycyny Wieku Rozwojowego
    Poznan, 61-709, Poland
  • NZLA Michałkowice Jarosz i partnerzy spolka lekarska
    Siemianowice Śląskie, 41-103, Poland
  • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.
    Tarnów, 33-100, Poland
  • Szpital im. Świętej Jadwigi Śląskiej, Oddział Dziecięcy
    Trzebnica, 55-100, Poland
  • SPSK nr 1 we Wrocławiu, Klinika Pediatrii i Chorób Infekcyjnych
    Wroclaw, 50-345, Poland
  • NZOZ Zawidawie - Centrum Medyczne "Zatorska"
    Wroclaw, 51-315, Poland
  • CSISP. Centro Superior de Investigación en Salud Pública
    Almassora, 12550, Spain
  • CSISP. Centro Superior de Investigación en Salud Pública
    Castellon, 12006, Spain
  • CSISP. Centro Superior de Investigación en Salud Pública
    Catarroja, 46470, Spain
  • Hospital Universitario San Cecilio
    Granada, 18012, Spain
  • CSISP. Centro Superior de Investigación en Salud Pública
    L'Eliana, 46183, Spain
  • CSISP. Centro Superior de Investigación en Salud Pública
    Puçol, 46530, Spain
  • CSISP. Centro Superior de Investigación en Salud Pública
    Quart de Poblet, 46930, Spain
  • CSISP. Centro Superior de Investigación en Salud Pública
    Sagunto, 46500, Spain
  • Instituto Hispalense de Pediatria
    Seville, 41014, Spain
  • Hosptial Universitario Joan XXIII de Tarragona
    Tarragona, 43007, Spain
  • CSISP. Centro Superior de Investigación en Salud Pública
    Valencia, 46013, Spain
  • CSISP. Centro Superior de Investigación en Salud Pública
    Valencia, 46021, Spain
  • CSISP. Centro Superior de Investigación en Salud Pública
    Valencia, 46024, Spain
  • Hospital Comarcal Axarquía
    Vélez-Málaga, 29700, Spain
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2010, a primary completion of Jan 2012 and a completion of Jun 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2010
First posted
Oct 11, 2010
Start
Sep 2010
Primary completionActual
Jan 2012
CompletionActual
Jun 2012
Last update
May 21, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01218451
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Oct 11, 2010
Start date
Sep 2010
Primary completion
Jan 2012
Completion
Jun 2012
Last update
May 21, 2015

Study contacts

Baxter BioScience Investigator, MD
study director · Baxter Healthcare Corporation

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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