Clinical trial NCT00129129: Comparison of GSKBiologicals' Hib-MenCY-TT Vaccine vs Licensed Hib Conjugate or Meningococcal Vaccine
Official title: Evaluate Immuno and Safety of GSKBiologicals' HibMenCYTT vs Licensed Hib Conjugate Vaccine, Each Coadministered With Pediarix® and Prevnar®, in Healthy Infants. An Exploratory Control Group Will Receive Licensed Menomune® at 3 to 5 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Haemophilus Influenzae Type b
Neisseria Meningitidis
Keywords: Immunogenicity
Primary & booster vaccination
Infants
Meningococcal vaccine
Safety
Children
Hib disease
Meningococcal disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-08-11
Enrollment: 756
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is evaluating the safety and immunogenicity of GSK Biologicals' Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, each administered at 2, 4, and 6 months of age, and compared to licensed meningococcal serogroups A, C, Y, and W-135 polysaccharide vaccine administered at 3 to 5 years of age.

The safety and immunogenicity of a booster dose of Hib-MenCY-TT vaccine will be compared to a booster dose of licensed Hib conjugate vaccine, each administered at 12 to 15 months of age. The group primed with the Hib conjugate vaccine will re-randomized at 12-15 months of age to receive a booster dose of Hib-MenCY-TT or a booster dose of the Hib conjugate vaccine.

Detailed description: The non-inferiority of the immunogenicity, safety, and antibody persistence of Hib-MenCY-TT vaccine will be compared to ActHIB®, a monovalent Hib conjugate vaccine licensed in the US.

All subjects will be vaccinated at 2, 4, 6, and 12 to 15 months. The immunogenicity of the MenC and MenY antigens will be summarized.

MenC and MenY immunogenicity will be compared to Menomune® (a quadrivalent meningococcal A, C, Y, and W-135 plain polysaccharide vaccine licensed in the US) administered to children 3 to 5 years of age.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility criteria: Inclusion Criteria:

* For Groups A and B

  * Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
  * Healthy male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
  * Written informed consent obtained from the parent or guardian of the subject.
  * Free of obvious health problems as established by medical history and clinical examination before entering the study.
  * Born after a gestation period between 36 and 42 weeks.
  * Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrollment.
* For Group C

  * Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
  * Healthy male or female between, and including, 3 and 5 years of age at the time of the first vaccination.
  * Written informed consent obtained from the parent or guardian of the subject.
  * Free of obvious health problems as established by medical history and clinical examination before entering the study.

Exclusion Criteria:

-For Groups A and B

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s).
* Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliovirus, and/or Streptococcus pneumoniae; more than one previous dose of hepatitis B vaccine.
* History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, poliovirus, and/or Streptococcus pneumoniae disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including dry natural latex rubber.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Acute disease at time of enrollment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

For Group C

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the dose of study vaccine.
* Previous vaccination against Neisseria meningitidis.
* History of Neisseria meningitidis disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including dry natural latex rubber
* Major congenital defects or serious chronic illness.
* Acute disease at time of enrollment.
* Administration of immunoglobulins and/or any blood products within the 3 months preceding vaccination or planned administration during the study period.

Primary outcomes:
measure: Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value.
timeFrame: One month after the 3-dose primary vaccination course (at Month 5)
measure: Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes
timeFrame: One month after the 3-dose primary vaccination course (at Month 5)
measure: Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations
timeFrame: One month after the 3-dose primary vaccination course (at Month 5)
measure: Number of Subjects Reporting Any Grade 3 Symptoms
timeFrame: During the 4-day follow-up period after each primary vaccine dose
measure: Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value
timeFrame: One month after the fourth dose (at Month 11-14)
Secondary outcomes:
measure: Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values
timeFrame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
measure: Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers
timeFrame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
measure: Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values
timeFrame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
measure: Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers
timeFrame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
measure: Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4
timeFrame: One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group)
measure: Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4
timeFrame: One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group)
measure: Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values
timeFrame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
measure: Anti-polysaccharide C (Anti-PSC) Antibody Concentrations
timeFrame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
measure: Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values
timeFrame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
measure: Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations
timeFrame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
measure: Number of Subjects Reporting Medically Attended Visits
timeFrame: During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0
measure: Number of Subjects Reporting Rash
timeFrame: During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
timeFrame: During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0
measure: Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Values
timeFrame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
measure: Anti-PRP Antibody Concentrations
timeFrame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
measure: Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off
timeFrame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
measure: Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off
timeFrame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
measure: Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off
timeFrame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
measure: Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentration ≥ 0.1 International Units Per Milliliter (IU/mL)
timeFrame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
measure: Anti-diphtheria and Anti-tetanus Antibody Concentrations
timeFrame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
measure: Number of Subjects With Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentration ≥ 10.0 Milli-international Units Per Milliliter (mIU/mL)
timeFrame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
measure: Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentrations
timeFrame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
measure: Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL
timeFrame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
measure: Anti PT, Anti-FHA and Anti-PRN Antibody Concentrations
timeFrame: Prior to the primary vaccination course (at Day 0)
measure: Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8
timeFrame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
measure: Anti-poliovirus Types 1, 2 and 3 Antibody Titers
timeFrame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
measure: Number of Subjects With Vaccine Response to PT, FHA and PRN
timeFrame: One month after the 3-dose primary vaccination course (at Month 5)
measure: Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms
timeFrame: Within 4 days (Day 0-3) after the 3-dose primary vaccination
measure: Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms
timeFrame: Within 8 days (Day 0-7) after the 3-dose primary vaccination
measure: Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms
timeFrame: Within 4 days (Day 0-3) after the 3-dose primary vaccination
measure: Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms
timeFrame: Within 8 days (Day 0-7) after the 3-dose primary vaccination
measure: Number of Subjects Reporting Unsolicited Adverse Events (AEs)
timeFrame: From Dose 1 (at Day 0) through Day 30 following the last vaccine dose administered (Day 30 post Month 4 vaccination for MenHibrix and ActHIB groups, Day 30 post Month 1 for Menomune Group).
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
timeFrame: During the entire Primary Phase of the study, from Day 0 up to the end of Primary Phase safety follow-up period (6 months after the last vaccination).
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
timeFrame: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.
measure: Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs)
timeFrame: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine
measure: Number of Subjects Reporting Rash
timeFrame: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.
measure: Number of Subjects Reporting Emergency Room (ER) Visits or Visits to Physicians' Office, Related or Not to Common Illnesses
timeFrame: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.
measure: Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y)
timeFrame: One month post fourth dose vaccination (at Month 11-14)
measure: Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y)
timeFrame: One month post fourth dose vaccination (at Month 11-14)
measure: Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y)
timeFrame: One month post fourth dose vaccination (at Month 11-14)
measure: Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y)
timeFrame: One month post fourth dose vaccination (at Month 11-14)
measure: Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL)
timeFrame: One month after fourth dose vaccination (at Month 11-14)
measure: Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL)
timeFrame: One month after fourth dose vaccination (at Month 11-14)
measure: Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL)
timeFrame: One month after fourth dose vaccination (at Month 11-14)
measure: Concentration of Antibodies Against Streptococcus Pneumonia Serotypes
timeFrame: One month post fourth dose vaccination (at Month 11-14)
measure: Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Equal to or Above the Cut-off Values
timeFrame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
measure: Anti-PRP Antibody Concentrations
timeFrame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
measure: Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values
timeFrame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
measure: rSBA-MenC Antibody Titers
timeFrame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
measure: Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values
timeFrame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
measure: rSBA-MenY Antibody Titers
timeFrame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
measure: Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values
timeFrame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
measure: hSBA-MenC Antibody Titers
timeFrame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
measure: Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values
timeFrame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
measure: hSBA-MenY Antibody Titers
timeFrame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
measure: Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Equal to or Above the Cut-off Values
timeFrame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
measure: Anti-PSC Antibody Concentrations
timeFrame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
measure: Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above the Cut-off Values
timeFrame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
measure: Anti-PSY Antibody Concentrations
timeFrame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
measure: Number of Subjects With Anti-tetanus Antibody Concentration Equal to or Above 0.1 International Units Per Milliliter (IU/mL)
timeFrame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
measure: Anti-tetanus Antibody Concentrations
timeFrame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
measure: Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms
timeFrame: Within 4 days (Day 0-3) after fourth dose vaccination
measure: Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms
timeFrame: Within 8 days (Day 0-7) after fourth dose vaccination
measure: Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms
timeFrame: Within 4 days (Day 0-3) after fourth dose vaccination
measure: Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms
timeFrame: Within 8 days (Day 0-7) after fourth dose vaccination
measure: Number of Subjects Reporting Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day follow-up period following the fourth dose
measure: Number of Subjects Reporting New Onset of Chronic Illness(es)
timeFrame: From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up
measure: Number of Subjects Reporting Rash
timeFrame: From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up
measure: Number of Subjects Reporting Emergency Room (ER) Visits or Physicians Office Visits Related or Not to Common Illnesses
timeFrame: From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up
measure: Number of Subjects Reporting Large Swelling Reactions of the Injected Limb(s)
timeFrame: Within 4 days (Day 0-3) and within 8 days (Day 0-7) following the fourth dose
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Fountain Valley
country: United States
facility: GSK Investigational Site
state: California
city: Centennial
country: United States
facility: GSK Investigational Site
state: Colorado
city: Norwich
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Marietta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Des Moines
country: United States
facility: GSK Investigational Site
state: Iowa
city: Bardstown
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Bossier City
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: New Bedford
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Bronx
country: United States
facility: GSK Investigational Site
state: New York
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Boardman
country: United States
facility: GSK Investigational Site
state: Ohio
city: University Heights
country: United States
facility: GSK Investigational Site
state: Ohio
city: Beaver Falls
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Greenville
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Norristown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Rydal
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Warwick
country: United States
facility: GSK Investigational Site
state: Rhode Island
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Bryant KA, Marshall GS. Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011 Jul;10(7):941-50. doi: 10.1586/erv.11.90.
citation: Marchant CD, Miller JM, Marshall GS, Blatter M, Aris E, Friedland LR, Boutriau D; HibMenCY-TT 005 Study Group. Randomized trial to assess immunogenicity and safety of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine in infants. Pediatr Infect Dis J. 2010 Jan;29(1):48-52. doi: 10.1097/INF.0b013e3181c3ce88.
citation: Marshall GS, Marchant CD, Blatter M, Aris E, Boutriau D, Poolman JT, Friedland LR, Miller JM. Immune response and one-year antibody persistence after a fourth dose of a novel Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY) at 12 to 15 months of age. Pediatr Infect Dis J. 2010 May;29(5):469-71. doi: 10.1097/INF.0b013e3181cdd379.
citation: Marshall GS, Marchant CD, Blatter M, Friedland LR, Aris E, Miller JM. Co-administration of a novel Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine does not interfere with the immune response to antigens contained in infant vaccines routinely used in the United States. Hum Vaccin. 2011 Feb;7(2):258-64. doi: 10.4161/hv.7.2.14170. Epub 2011 Feb 1.